JP6453769B2 - Induction cauterization method, system and induction cautery equipment - Google Patents

Description

  The present invention relates to a high-frequency ablation method for cauterizing nerves and to a high-frequency ablation system. In addition, the present invention relates to an induction cautery facility for realizing the induction cauterization method.

  Plant nerve abnormalities are important factors that play an important role in the development, change, and development of many diseases. For example, renal sympathetic nerves have an important role in many diseases such as hypertension, chronic heart failure, renal failure, carbohydrate metabolism disturbances, polycystic ovary syndrome, etc., whose activity is excessively enhanced. Also, for example, the effect of increased vagal activity on peptic ulcers is considered and studied for a long time by the medical community, but vagal nerve cutting can suppress gastric acid secretion. Also, for example, the mechanism of asthma attacks has not been fully elucidated until now, but there is sufficient evidence that plant neuropathy is an important factor in asthma attacks and development.

  In the middle of the 20th century, there was an attempt by scholars to treat treatment-resistant hypertension as a result of surgical resection. Although this resection was abandoned because it initially caused serious complications, these clinical trials also show the therapeutic value of the resection for renal sympathetic blockade .

  In recent years, percutaneous renal sympathetic nerve cauterization using minimally invasive intervention techniques has begun to be applied clinically, and better results have been obtained. At the same time, the high-frequency ablation technique is widely applied to the treatment of various lesion tissues such as heart, cancerous tumor and skin. Specifically, when a high-frequency energy is radiated to the lesion tissue, it is converted into thermal energy, and the feature is relatively concentrated on the lesion tissue. Perform invasive surgical procedures.

  The main technical problem to be solved by the present invention is to provide a high-frequency cauterization method for cauterizing nerves.

  Another technical problem to be solved by the present invention is to provide a high-frequency cauterization system for realizing the high-frequency cauterization method.

  Yet another technical problem to be solved by the present invention is to provide a high-frequency ablation equipment for realizing the high-frequency ablation method.

  In order to realize the above object of the present invention, the present inventor adopts the following technical solution in the present invention.

One technical solution is
Step 1 for collecting and storing basic patient information;
After the distal end of the radiofrequency ablation catheter reaches the target lumen, step 2 for targeting the target tissue by measuring volume impedance and performing radiofrequency electrode pasting;
Steps for generating induction parameters (hereinafter abbreviated as “instruction parameters”) from the data in the database based on the basic information of the patient, selecting a set of instruction parameters, and starting the induction process 3 and
Step 4 for monitoring and measuring changes in volume impedance of the target tissue during the process of radiofrequency ablation and adjusting the radiofrequency parameters;
It is determined whether or not the volume impedance of the target tissue is within a preset volume impedance threshold range. If the determination result is “YES”, the high frequency energy emission is stopped and the high frequency parameter is stored, and the determination result is “ If NO, step 5 for repeating step 4 until the volume impedance of the target tissue is within a preset volume impedance threshold range,
This is a high-frequency cauterization method for cauterizing nerves.

  As one preferred embodiment of the above-described high-frequency cauterization method, the instruction parameters in the step 3 include high-frequency output power, high-frequency energy radiation duration, high-frequency energy radiation stop interval time, number of repetitions, set temperature, volume impedance threshold value. Including an induction cauterization method.

  As another preferred embodiment of the above-described radiofrequency ablation method, the step 4 further includes a step of monitoring and measuring a change in the temperature of the target tissue, and simultaneously monitoring and measuring a change in the volume impedance of the target tissue. It is determined whether the temperature of the target tissue has exceeded a preset temperature threshold. If the determination result is “NO”, high-frequency energy emission is continued. If the determination result is “YES”, high-frequency energy emission is continued. This is a high-frequency cauterization method in which the high-frequency parameters are memorized with automatic warning.

Another technical solution is
Central processing arithmetic device and control module, high-frequency energy radiation module, volume impedance measurement module, temperature monitoring measurement module connected to the central processing arithmetic device and control module, and alarm connected to the central processing arithmetic device and control module, respectively As well as an automatic storage module,
The central processing unit and the control module are used to generate instruction parameters, and control the radio frequency energy radiation module according to the measurement results of the volume impedance measurement module and the temperature monitoring measurement module. Used,
The volume impedance measurement module is used to measure the volume impedance of the target tissue and provides a basis for targeting the target tissue and determining the degree of attenuation of high frequency energy;
The temperature monitoring measurement module is used to monitor and measure the temperature around the target tissue in real time, preventing excessive damage to the target lumen;
The alarm and automatic storage module is used for integrated analysis of signals from the monitoring and measurement module, and for immediate alarm when the measured value exceeds a preset safety threshold, and is used in the process of high-frequency ablation. Used to organize and memorize the teaching parameters and collected data information,
Induction cautery system.

As a preferred embodiment of the above-mentioned high-frequency ablation system, further includes an intracavity optical tomographic image processing module and an intracavity ultrasonic image processing module respectively connected to the central processing unit and the control module,
The intracavity optical tomography processing module is used for monitoring and measuring a real-time moving image on a blood vessel wall around a target tissue,
The intracavitary ultrasound image processing module is used to perform ultrasound image monitoring measurements on the vessel wall around the target tissue;
Induction cautery system.

Yet another technical solution is
Includes an induction cautery catheter, a control handle and a temperature controlled induction heat condensing device
A stripe-shaped connection electrode is mounted on the intermediate portion of the high-frequency ablation catheter, a high-frequency electrode is formed at the distal end of the high-frequency ablation catheter, and the high-frequency electrode is connected to the control handle by the stripe-shaped connection electrode,
The control handle includes a catheter guide control handle for controlling the degree of bending of the distal end of the radiofrequency ablation catheter, and a catheter electrode control handle and a catheter electrode control auxiliary unit for controlling the degree of spreading of the radiofrequency electrode. Including the handle,
The temperature-controlled high-frequency heat condensation apparatus includes a central processing unit and a control module, a high-frequency energy radiation module, a volume impedance measuring module, a temperature monitoring and measuring module, and the central processing unit connected to the central processing unit and the control module, respectively. Including an alarm and automatic storage module connected to the device and the control module;
An integrated interface is installed at the rear end of the control handle, and the temperature-controlled high-frequency heat condensation apparatus is connected to the integrated interface installed in the control handle by an integrated cable.
Induction cautery equipment.

  As one preferred embodiment of the above-mentioned high-frequency ablation equipment, there is a high-frequency ablation equipment in which a perforated wall portion is installed at the affixing wall and high-frequency energy radiation position of the high-frequency electrode.

As one preferred embodiment of the above-mentioned induction cautery equipment, including a guide catheter installed outside the induction cautery catheter, the guide catheter has an anti-electromagnetic interference function,
The guide catheter includes a hollow cylindrical tube body, the tube body has an end at the front end, a rear end interface is installed at the rear end of the tube body, and the tube body and the rear end interface are A shield net knitted from a conductive material, the conductive material laid across the tube wall of the tube so as to form a shield net having an annular closed shape, and the shield net is Pulled out from the rear end interface to form a connector at the rear end interface, the connector being grounded;
Induction cautery equipment.

As one preferred embodiment of the above-mentioned high-frequency ablation equipment, the high-frequency electrode has both a temperature measurement function and a volume impedance measurement function,
The high-frequency electrode includes a high-frequency energy radiation point, and the high-frequency energy radiation point is simultaneously a volume impedance measurement point,
A thermocouple for measuring temperature is formed by bonding a second material to the high-frequency electrode, and the second material is a material different from a material for forming the high-frequency electrode.
Induction cautery equipment.

As one preferred embodiment of the above-mentioned induction cautery equipment, a groove is formed on the surface of the induction cautery catheter,
The high-frequency ablation catheter includes a support catheter disposed at a central portion of the high-frequency ablation catheter, and a plurality of conductors disposed on an outer surface of the support catheter, and the plurality of conductors is a circumference of the support catheter. Arranged around the direction, and each wire is extended along the length of the support catheter, and a sealing layer for covering the wire is disposed outside each wire. The adjacent sealing layer forms a groove in the outer surface of the support catheter;
Induction cautery equipment.

As one preferred embodiment of the above-mentioned induction cautery, the catheter tube of the induction cautery catheter is a cable-integrated catheter tube manufactured by a cable manufacturing method, and one end of the catheter tube has a control handle. Used to connect, the other end of the catheter tube is used to manufacture the electrode part,
Induction cautery equipment.

  In the induction cautery method of the present invention, the guidance parameter is provided before the induction cautery operation to prevent blinding of the radiofrequency ablation operation, and the target is cauterized using a plurality of types of monitoring and measuring means during the radiofrequency ablation operation. Real-time dynamic control of the nerves, guidance on control and understanding of the degree of nerve cauterization, improving the therapeutic effect and the appropriateness of the treatment, while preventing complications.

FIG. 1 is a flowchart of the process for updating the induction parameters of induction cautery. FIG. 2 is a block showing the data processing function of the induction cautery system. FIG. 3 is a flowchart of data processing in the process of high-frequency ablation. FIG. 4 is a perspective view showing the structure of the temperature-controlled high-frequency ablation equipment in the first embodiment. FIG. 5 is a schematic diagram showing the structure of the integrated cable of the temperature-controlled high-frequency cautery equipment in FIG. FIG. 6a is a schematic view showing a structure of the high-frequency cautery catheter and the control handle of the temperature-controlled high-frequency ablation equipment shown in FIG. 4 when the saddle-shaped high-frequency electrode stent is in a closed state. FIG. 6B is a schematic view showing the structure of the high-frequency cautery catheter and the control handle of the temperature-controlled high-frequency ablation equipment shown in FIG. 4 when the saddle-shaped high-frequency electrode stent is in a stretched state. FIG. 6c is a schematic view showing the structure of the high-frequency ablation catheter and the control handle of FIG. 4 when the front end of the induction catheter is in a curved state. FIG. 7a is an enlarged view of the front end of the radiofrequency ablation catheter in the radiofrequency ablation catheter as shown in FIG. 6a. FIG. 7b is an enlarged view of the front end of the radiofrequency ablation catheter in the radiofrequency ablation catheter as shown in FIG. 6b. FIG. 7c is a schematic cross-sectional view of a saddle-shaped high-frequency electrode stent at the front end of the high-frequency ablation catheter in the high-frequency ablation catheter as shown in FIG. 6b. FIG. 8a shows the state of the control handle of the temperature-controlled high-frequency ablation equipment in FIG. 4 when the saddle-shaped high-frequency electrode stent is in the closed state and the front end of the high-frequency ablation catheter is in the straightened state. FIG. FIG. 8b shows the change in the state shown when the control handle of the temperature-controlled radiofrequency ablation equipment in FIG. 4 is when the saddle-shaped radiofrequency electrode stent is in the expanded state and the front end of the radiofrequency ablation catheter is in the curved state. It is the shown schematic. FIG. 9 is a schematic diagram showing the coronal surface structure of the integrated interface of the control handle of the temperature-controlled induction cautery equipment in FIG. FIG. 10 is a schematic diagram showing the connection of the integrated interface as shown in FIG. FIG. 11a is a schematic diagram showing the basic structure of a scissor-type transluminal perforation type radiofrequency ablation catheter having a pointed protrusion type perforation structure in Example 2. FIG. 11b is a schematic view showing the coronal surface presented when the saddle-like transluminal radiofrequency ablation catheter as shown in FIG. FIG. 12a is a schematic diagram showing the basic structure of a long puncture needle type transluminal perforation type radiofrequency ablation catheter having a long puncture needle type perforation structure in Example 3. FIG. It is the schematic which showed the perforation state which the long puncture needle type transluminal radiofrequency ablation catheter as shown in FIG. 12a exhibited. FIG. 13 is a schematic view showing a basic structure of a spherical sac-like transluminal radiofrequency ablation catheter in Example 4. FIG. 14 is a schematic view showing a state of perforation presented by a spherical sac-like transluminal radiofrequency ablation catheter as shown in FIG. FIG. 15a is a schematic diagram showing heat energy transfer in percutaneous renal sympathetic nerve cauterization in the prior art. FIG. 15b is a schematic diagram showing thermal energy transfer in the transluminal and permural nerve ablation method of the present invention. FIG. 16 is a schematic view showing the structure of a saddle-shaped high-frequency electrode stent having both a temperature measurement function and a volume impedance measurement function in Example 5. FIG. 17a is a schematic diagram showing the structure of a long puncture needle type high-frequency electrode having both a temperature measurement function and a volume impedance measurement function in Example 6. FIG. 17b is a schematic view showing a spread state exhibited by the long puncture needle type high-frequency electrode as shown in FIG. 17a. FIG. 18a is a schematic view showing the principle of joining the second material to the high frequency electrode by plating. FIG. 18b is a schematic view showing the principle of bonding the second material to the high-frequency electrode by the insertion method. FIG. 18c is a schematic diagram illustrating the principle of bonding the second material to the high-frequency electrode by a crimping method. FIG. 19 is a schematic diagram showing the operating principle of the entire temperature-controlled high-frequency ablation equipment including a high-frequency electrode having both a temperature measurement function and a volume impedance measurement function. FIG. 20 is a circuit diagram for measuring the volume impedance. FIG. 21 is a circuit diagram for measuring temperature having a temperature compensation circuit. FIG. 22A is a schematic diagram showing high-frequency energy radiation when a circuit is constituted by a single high-frequency electrode and a body surface electrode. FIG. 22B is a schematic diagram showing high-frequency energy radiation when a circuit is constituted by dual high-frequency electrodes. FIG. 23 is a schematic view showing a state in which a conducting wire is arranged in a high-frequency ablation catheter having grooves on its surface. FIG. 24a is a schematic cross-sectional view of a radiofrequency ablation catheter having a groove in Example 7. FIG. FIG. 24 b is a schematic cross-sectional view of a high-frequency ablation catheter having a groove in Example 8. FIG. 25 is a schematic cross-sectional view of a guide catheter of a high-frequency ablation catheter having a groove. FIG. 26a is a schematic view showing a gap existing between the induction catheter and the guide catheter as shown in FIG. FIG. 26b is a schematic view showing a gap existing between a high-frequency ablation catheter and a guide catheter in the prior art. FIG. 27a shows the inner layer of nickel-titanium wire and enamel by peeling off the covering layer of the cable near the high frequency electrode of the catheter tube of the high frequency ablation catheter after the manufacture of the cable type high frequency ablation catheter in Example 9 It is the schematic which showed the state which made the copper wire leak. FIG. 27b is a schematic view showing a state in which the exposed nickel-titanium wire insulating layer in FIG. 27a is peeled off and the shape of the peeled nickel-titanium wire is formed into the shape of a high-frequency electrode stent. FIG. 27c shows the insulation of the nickel-titanium wire from which the insulating layer in FIG. 27b is peeled by covering the proximal end and the distal end with a heat-shrinkable tube, and leaking the middle portion to form a conductive portion. It is the schematic which showed the state which carried out. FIG. 27d is a schematic view showing a state where the insulating layer of the exposed enameled copper wire in FIG. 27a is peeled off and the peeled enameled copper wire is wound around the exposed portion of the nickel-titanium wire to form a thermocouple. FIG. FIG. 27e is a schematic view showing a state in which the wound enameled copper wire in FIG. 27d is covered with a platinum ring to form an electrode portion. FIG. 27f is a schematic view showing a state in which the expansion / contraction control line is penetrated through the central hole of the catheter tube of the high-frequency cautery catheter. FIG. 27g is a schematic view showing a state in which the front end of the high-frequency electrode stent made of nickel-titanium wire is fixed integrally with the front end of the expansion / contraction control line. FIG. 28 is a schematic view showing the structure of a guiding catheter having an anti-electromagnetic interference function in Example 10. FIG. 29a is a perspective view of a guiding catheter as shown in FIG. FIG. 29b is a cross-sectional view of a guiding catheter as shown in FIG. FIG. 29c is a schematic view showing a state where the shielding net is developed in the guiding catheter as shown in FIG. FIG. 30 is a schematic diagram showing the electromagnetic wave shielding principle of the guiding catheter as shown in FIG. FIG. 31 is a schematic view showing a state in which the shielding net is grounded by the integrated cable. FIG. 32 is a schematic view showing a state in which the shielding net is grounded by the skin electrode. FIG. 33 is a schematic view showing a state in which the shielding net is directly grounded by a lead wire. FIG. 34 is a schematic view showing the structure of a shielding network of a guiding catheter that does not include a hemostasis valve and has an anti-electromagnetic interference function.

The technical contents of the present invention will be specifically described below with reference to the drawings and preferred embodiments.
In order to prevent blinding of the prior art radiofrequency ablation surgery, the present invention provides a radiofrequency ablation method having instruction parameters and monitoring and measuring means, and a radiofrequency ablation system and an induction ablation equipment for realizing the radiofrequency ablation method. I will provide a.

  As shown in FIG. 1, in the induction method of the present invention, the teaching parameters used are initially derived from existing clinical and animal experimental data and are continuously updated and adjusted by subsequent clinical experiments. be able to. Before starting the radiofrequency ablation surgery, the radiofrequency ablation system uses one or more sets of data from the database based on the patient's basic information (eg gender, age, medical history, physiological indicators, biochemical indicators, living area). The teaching parameters can be automatically generated. The generated guidance parameters are selectively used by the operator. All teaching parameters in each set are of greater teaching significance because they are derived from experimental data in the database that have a higher cure rate for similar patients. Guidance parameters include high frequency output power, high frequency energy radiation duration, high frequency energy radiation stop interval time, number of repetitions, set temperature, volume impedance threshold, and other related information such as volume impedance threshold range, temperature threshold range, etc. Can further be included. Among them, each parameter in the teaching parameter can be a constant value, and can also be a numerical range worth referencing. The meanings included in these teaching parameters are the volume impedance of the electrodes in different areas, electrophysiological activity, preset temperature, output power and output time, product of power and time, and the above parameters before and after treatment. Includes comparative differences. The surgeon himself selects and uses one parameter from these guidance parameters, and makes adjustments according to the degree of damage to the nerve in the course of radiofrequency ablation surgery. After completing the radiofrequency ablation surgery, the radiofrequency ablation system can automatically store the parameters used in the surgical procedure in the database and update the database. These parameters are used to subsequently generate more accurate guidance parameters. The teaching parameters are stored in the associated device and provide long-term retrospective evidence.

  In the high-frequency ablation method of the present invention, in order to accurately determine the ablation area of the target tissue and determine the degree of nerve ablation, volume impedance measurement is performed on the target tissue before, during, and after the operation. Do each. Since the target tissue has a low volume impedance characteristic, the distribution state of the target tissue can be probed by a special saddle-shaped high-frequency electrode stent. In addition, degeneration / dehydration of the target tissue by high-frequency ablation directly increases the volume impedance of the target tissue, so the degree of nerve ablation is indirectly determined by comparing changes in the volume impedance of the target tissue before and after high-frequency ablation. You can also. Therefore, in the radiofrequency ablation method of the present invention, the target tissue is targeted by measuring the volume impedance of the target tissue before surgery, and the accurate selection of the radiofrequency electrode position is instructed; By monitoring and measuring the change in volume impedance, the degree of damage / cauterization to the target tissue and the blood vessel wall is determined, and the accurate cauterization progress time or cauterization stop time is determined.

  In order to ensure the safe progression of high-frequency ablation surgery, the high-frequency ablation method and high-frequency ablation system of the present invention have additional steps and equipment for real-time monitoring and measurement. For example, a volume impedance measurement module is added to perform real-time monitoring and measurement of volume impedance in the process of high-frequency ablation, but a temperature monitoring and measurement module is added to perform real-time monitoring and measurement of temperature in the process of high-frequency ablation. doing. Furthermore, for example, an intracavity optical tomographic image processing module is added to monitor and measure a real-time moving image on the blood vessel wall around the target tissue. An intracavitary ultrasound image processing module is added to perform measurements. When the situation where the temperature of the blood vessel wall around the target tissue exceeds the set temperature is monitored and measured, high-frequency energy emission is stopped and an automatic alarm is given. Thereby, excessive damage to the blood vessel wall around the target tissue can be prevented.

  The induction cautery method and the induction cautery system of the present invention have been generally described, but will be specifically described below with reference to the drawings.

  As shown in FIG. 2, the high-frequency ablation system of the present invention includes a central processing unit and control module 1, a high-frequency energy radiation module 2 connected to the central processing unit and control module 1, a volume impedance measurement module 3, It includes a temperature monitoring and measuring module 4 and an alarm and automatic storage module 5 connected to the central processing unit and the control module 1. In addition, the high-frequency ablation system further includes an intracavity optical tomographic image processing module 6 and an intracavity ultrasonic image processing module 7 connected to the central processing unit and the control module 1.

  Among them, the central processing unit and the control module 1 are the core of the entire high-frequency ablation system, and are used to collect data used by each functional module connected thereto and to analyze the data. The central processing unit and the control module 1 first generate instruction parameters based on the basic information of the patient, then target the target tissue based on the volume impedance measurement result, and finally, each monitoring measurement module ( Based on the measurement results of the volume impedance measurement module 3, the temperature monitoring measurement module 4, the intracavity optical tomography processing module 6, and the intracavity ultrasound image processing module 7). The control is performed for the process of high-frequency energy radiation performed by the high-frequency energy radiation module 2.

  The high-frequency energy radiation module 2 emits high-frequency energy under the control of the central processing unit and the control module 1, and cauterizes the nerve that is the target tissue.

  The volume impedance measurement module 3 is used to measure the volume impedance of the target tissue and provides a basis for targeting the target tissue and determining the degree of attenuation of the high frequency energy; the temperature monitoring measurement module 4 is a temperature around the target tissue. To prevent excessive damage to the target lumen; the intraluminal optical tomography module 6 performs real-time video monitoring on the vessel wall around the target tissue Intracavitary ultrasound image processing module 7 is used to perform supervised measurement of the ultrasound image of the blood vessel wall around the target tissue; alarm and automatic storage module 5 is used for each monitoring measurement module (volume impedance measurement module 3, Temperature monitoring measurement module 4, intracavity optical tomography processing module 6, intracavity ultrasonic image processing module 7 Integrated analysis of the signals from the system, and an automatic alarm for the guidance parameters and collected data information used in the process of high-frequency ablation are used for immediate warning when the safety threshold is exceeded. Used for.

  Hereinafter, the induction cauterization method of the present invention will be specifically described with reference to a data processing flowchart as shown in FIG. Specifically, the induction cautery method includes the following steps.

  Step 1: Prior to high-frequency cautery surgery, the patient's basic information is stored, and the patient's first name, last name, age, sex, race, living area, blood pressure, heart rate, and other data are collected. Perform a full analysis on whether the patient develops diseases of other organs such as the heart and lungs, and provide conditions for data analysis and database construction.

  Step 2: Using conventional intervention techniques, the radiofrequency ablation catheter is selectively inserted into the target lumen of the patient; after the distal end of the radiofrequency ablation catheter has reached the target lumen, the target lumen Target volume is measured by measuring the volume impedance of the target lumen to determine the location of the radiofrequency ablation and the direction of radiofrequency ablation; then on the control handle in the radiofrequency ablation catheter A high frequency electrode is installed in the ablation area selected by the catheter controller, and the high frequency electrode is attached to the wall.

  In order to reduce damage to the target lumen due to high-frequency cauterization, the present invention further provides a high-frequency electrode having a perforated wall (the perforated wall is installed at the position where the high-frequency electrode is attached, that is, the high-frequency energy radiation position) ), The high-frequency electrode can penetrate the blood vessel wall or penetrate the blood vessel wall, reach the outside of the blood vessel wall and emit high-frequency energy to the perivascular plant plexus. The specific structure and technical effect will be specifically described with reference to the second and fourth embodiments.

  When using a high-frequency electrode with a perforation (see below for its structure), the perforation is performed after the high-frequency electrode is applied, the perforation is inserted into the blood vessel wall, and is necessary for clinical treatment Reach a certain depth.

  In practice, one or more methods for determining whether the high-frequency electrode was in the stuck wall state can be adopted. For example, a pressure sensor is installed on the control handle to determine the pressure at which the electrode ascending portion is pulled down to determine the state of the high-frequency electrode sticking wall, or a tensile stress sensor is installed on the expansion / contraction controller on the control handle. The tensile strength value detected by the stress sensor is fed back to the central processing unit and displayed as the actual tensile stress. Here, the tensile strength value range collected by animal experiments can be used as a reference in actual surgery.

  Before starting the process of high-frequency ablation, the high-frequency electrodes that are not yet in the stuck wall state by measuring the volume impedance values of each high-frequency electrode one by one to determine whether these volume impedance values are close to each other Determine whether exists. If the high frequency electrode is present, the adjustment is performed immediately and step 2 is repeated. After confirming that all the high-frequency electrodes are already pasted by the tensile stress value and the volume impedance value, the high-frequency cautery treatment is started.

  Electrophysiological data (for example, volume impedance, nerve impulse activity, smooth muscle rhythm, etc.) can be selectively collected after the high-frequency electrode is stuck (and perforated) and before high-frequency energy emission. The collected electrophysiological data is used for data analysis in the surgical process.

  Step 3: One or more sets of instruction parameters are generated from the data in the database based on the basic patient information input in Step 1. Guidance parameters include high frequency output power, high frequency energy radiation time, set temperature and volume impedance threshold, etc., and other related information such as volume impedance change range, high frequency output power change range, tissue temperature change range, etc. Etc. can be further included. Among them, each parameter in the teaching parameter can be a constant value, and can be a numerical value range worth referencing. The surgeon selects a set of parameters and initiates the process of radiofrequency ablation.

  Step 4: Monitor and measure the change in volume impedance of the target tissue during the process of high frequency ablation, thereby adjusting the high frequency parameters. If the effect is not ideal, it can be changed to another mode, but the high frequency parameters can be fine-tuned. Adjustable high frequency parameters are set temperature, high frequency output power, high frequency energy radiation time.

  In the process of high-frequency cauterization, it further includes a plurality of types of dynamic monitoring and measuring means to perform real-time monitoring and measurement. Thereby, the effectiveness of high-frequency ablation can be ensured, and damage to the blood vessel wall (target lumen) around the target tissue can be reduced to a minimum. When a monitoring measurement result indicating that the measured value exceeds the critical value is displayed, the high-frequency energy emission is stopped, an automatic alarm is issued, and the high-frequency parameter is stored. Otherwise, continue high-frequency energy radiation.

  For example, in the process of dynamically monitoring and measuring the temperature in real time, the temperature sensor and the temperature monitoring and measuring system apparatus in the temperature monitoring and measuring module 4 are used, and the ambient temperature of the distal end of the radiofrequency ablation catheter in the process of the radiofrequency ablation surgery. Real-time dynamic monitoring measurements can be taken and the ambient temperature of the tissue can be measured to determine if the temperature value has exceeded a predetermined threshold. If the determination result is “NO”, the high-frequency energy emission is continued, and if the determination result is “YES”, the high-frequency energy emission is stopped, an automatic alarm is given, and the high-frequency parameter is stored.

  In addition, in the process of radiofrequency ablation, real-time dynamic monitoring and measurement of intraluminal optical tomograms and real-time dynamic monitoring and measurement of intraluminal ultrasound images are included. Imaging and determining whether the temperature of the target lumen and the degree of damage to the target lumen exceed a predetermined threshold. If the determination result is “NO”, the high-frequency energy emission is continued, and if the determination result is “YES”, the high-frequency energy emission is stopped, an automatic alarm is given, and the high-frequency parameter is stored.

  Step 5: In the process of high-frequency ablation, the change in volume impedance of the target tissue is monitored in real time or discontinuously to determine whether the volume impedance of the target tissue is within a preset volume impedance threshold range; If the determination result is “YES”, the high-frequency energy emission is stopped and the high-frequency parameter is stored, and if the determination result is “NO”, the volume impedance of the target tissue is within a preset volume impedance threshold range. Step 4 is repeated until.

  In Step 5, when the determination result is “YES”, after the high frequency energy emission is stopped, the electrophysiological data is measured again, and the electrophysiological data is associated with the high frequency parameter and then stored together in the database.

  In addition, the induction ablation method further includes step 6. Step 6: Collect data on patient biometrics (eg blood pressure) during patient visit guidance / monitoring measurements to assess and calibrate the data in the database and replace the existing guidance parameters. In addition, data relating to the biological information index is stored in the database after being associated with the high frequency parameter. Stored biometric data and high-frequency parameters can be used to track treatment effects and are used by medical institutions and physicians to statistically analyze and optimize data in the database You can also. For example, after surgery, the patient's blood pressure can be measured periodically and changes in the patient's blood pressure can be tracked and monitored. Based on these data, it is possible to determine the therapeutic effect of renal nerve radiofrequency ablation performed to treat resistant hypertension.

  Create personal profiles in time series using the above data, store these personal profiles permanently in the storage device of the high-frequency ablation equipment, build a database, and provide evidence that will be retroactive over the long term it can.

  By investigating and statistically analyzing a large number of individual profiles in the database, it is possible to analyze the best surgical parameter interval of patients with different backgrounds such as different ethnicities, different regions, different countries, different ages. Therefore, a doctor can be instructed when a high-frequency cautery operation is performed on a group of patients having different statuses and different backgrounds.

  By establishing these methods, it is possible to analyze and study the causes and pathogenesis mechanisms related to the formation of hypertensive patient groups and to quantitatively analyze and study them, and to establish surgical methods for different patient groups.

  To summarize the above, the induction cautery method of the present invention can automatically generate instruction parameters that can be selectively used by the operator before starting the induction cautery operation, In order to perform monitoring control and adjustment for high-frequency ablation, real-time dynamic monitoring and measurement can be performed on volume impedance, temperature, intraluminal optical tomogram and intraluminal ultrasound image, so a kind of science and This is a high-frequency cauterization method that is safe and has teaching significance.

  The high-frequency ablation system of the present invention realizes real-time dynamic monitoring and measurement of the ablated target nerve by measuring the volume impedance of the nerve ablation site, and controls the degree of nerve ablation. Guidance on grasping and improving the effectiveness of treatment and the validity of treatment, while preventing the occurrence of complications.

  The induction cautery method and induction cautery system of the present invention is used for renal arterial nerve radiofrequency ablation performed to treat resistant hypertension, but also used for other radiofrequency ablation Has been. For example, the radiofrequency ablation method and the radiofrequency ablation system of the present invention include a renal sympathetic nerve radiofrequency ablation method that is inserted into a vein via a vein, which is also performed to treat resistant hypertension, and a urethra. It has been used for renal sympathetic radiofrequency cauterization to be inserted into the renal pelvis. Further, for example, the induction cautery method and the induction cautery system of the present invention are performed to treat vagus nerve branch radiofrequency ablation via the duodenum and to penetrate the duodenum performed to treat duodenal ulcer and to treat asthma. Used for radiofrequency ablation of the vagus nerve branch through the trachea / bronchi and through the trachea / bronchus, and percutaneous sympathetic radiofrequency ablation of the abdominal artery performed to treat diabetes .

Example 1
The present invention provides an induction cauterization method and an induction cauterization system, and further provides an induction cautery facility for realizing the above method. Hereinafter, the induction cautery system of the present invention will be described using temperature control type induction cautery equipment as shown in FIGS. 4 to 10 as an example.

  4 includes a high-frequency ablation catheter 10 and a control handle 20 for controlling the forward movement operation, the backward movement operation, and the bending operation of the high-frequency ablation catheter 10. The proximal end (i.e., the rear end, the end far from the patient's body) is connected to the control handle 20, and the distal end (i.e., the front end, the end close to the patient's body) of the radiofrequency ablation catheter 10 is provided with a perforation. A high-frequency electrode 12 is installed and used to cauterize a nerve that is a target tissue in a target lumen. The specific structure and technical effect of the high-frequency electrode provided with the perforated wall will be specifically described using Example 2, Example 3, and Example 4.

  The radiofrequency ablation catheter 10 further includes at least a temperature measurement electrode called a functional electrode and a volume impedance measurement electrode, except for the control handle 20. Among them, by sharing one high-frequency electrode and connecting it to different processing modules, two functions of temperature measurement function and high-frequency energy radiation function can be realized. The temperature measurement function can be realized by measuring the temperature using a thermocouple formed by bonding the electrode to the high frequency electrode. For the description of the high-frequency electrode having both the temperature measurement function and the volume impedance measurement function, reference is made to Example 5 and Example 6 below. Detailed description will not be repeated here.

  The temperature-controlled high-frequency cautery equipment further includes a temperature-controlled high-frequency heat condensing device 35 connected to a display device 36 (also referred to as a monitoring device). The temperature-controlled high-temperature apparatus 35 is connected to the control handle 20 via an integrated cable. Connected to. The integrated cable includes two ends respectively installed at both ends of the integrated cable 34, that is, a catheter side end 31 in the integrated cable, and a temperature-controlled high-frequency heat condensing device side end 37 in the integrated cable. The control-type high-frequency heat condensation apparatus side end portion 37 is sequentially connected to the catheter side end portion 31 of the integrated cable via the integrated cable 34, the plug flange 32, and the integrated cable coupling portion 33. The temperature-controlled high-frequency heat condensing device side end 37 in the integrated cable is inserted into the temperature-controlled high-frequency heat condensing device-side end connection socket 38 in the integrated cable installed in the temperature-controlled high-frequency heat condensing device 35. Used to realize the connection. The catheter side end 31 in the integrated cable is used for insertion into the catheter side end connecting socket or integrated interface 50 in the integrated cable installed at the proximal end of the control handle 20 to realize the connection (see FIG. 5).

  FIGS. 6a-8b show that the radiofrequency ablation catheter 10 and the control handle 20 are such that the distal end (ie, the front end) of the radiofrequency ablation catheter is in a straightened or curved state and the radiofrequency electrode is in a closed or stretched state. It is the schematic which shows the structure which had when there was.

  As shown in FIGS. 6a and 7a, the high-frequency ablation catheter includes a catheter tube, and a control handle 20 is connected to the proximal end of the catheter tube, and is placed in the middle portion of the catheter tube (in the middle of the high-frequency electrode 12). A stripe-shaped connection electrode is mounted on the distal end of the catheter tube, and a high-frequency electrode 12 is mounted on the distal end of the catheter tube. Yes. The specific structure and installation position regarding the perforated wall portion 13 are different depending on the high-frequency electrodes having different shapes. Examples 2 to 4 will be referred to for examples regarding specific shapes of the high-frequency electrode 12 and the wall 13. The high-frequency electrode 12 is connected to the control handle 20 by a stripe connection electrode, and an integrated interface 50 is installed in the control handle 20.

  A guide catheter 16 is installed outside the high-frequency ablation catheter 10 along its length. Regarding the installation method of the high-frequency ablation catheter 10 and the guide catheter 16, the drawings for explaining the seventh to tenth embodiments will be referred to and the following will be referred to for specific explanations. The guide catheter 16 has a stripe shape, and an intermediate portion thereof is parallel to an intermediate portion of the high-frequency electrode. The middle part of the guiding catheter 16 can be solid or hollow. The guiding catheter 16 and the high-frequency electrode 12 can be arranged in parallel, concentric circles, or other shapes. When the guide catheter 16 is a hollow catheter, an opening 14 is provided at the front end thereof, and a control handle 20 is inserted at the rear end thereof. The catheter branch 17 having a port is separated from the guide catheter 16 in front of or behind the control handle 20, and various liquids (for example, contrast medium, physiological saline, drug, etc.) are injected through the port of the catheter branch 17. Alternatively, various monitoring / measuring instruments (for example, a catheter for intraluminal ultrasound image processing, a spherical sac catheter, a catheter for intraluminal optical tomographic image processing, etc.) can be inserted. An expansion / contraction control line is installed along the length of the middle portion of the guide catheter 16, the front end of the expansion / contraction control line is fixed to the distal end of the high-frequency electrode 12, and the rear end of the expansion / contraction control line ( That is, the proximal end) is connected to a telescopic controller on the control handle 20.

  In addition, in order for the operator to easily determine the position of the radiofrequency ablation catheter, at least one mark portion having radiopaque properties is installed at the distal end of the radiofrequency ablation catheter 10. In the embodiment as shown in FIG. 1, the mark part 11 having X-ray opacity and the mark part 15 having X-ray opacity are respectively installed at the front end and the rear end of the high-frequency electrode 12.

  In the high-frequency ablation catheter 10, the high-frequency electrode 12 can be separated from the striped connection electrode. The basic structure is that there is one connection point (not shown) and one separable separation device (not shown) between the high-frequency electrode 12 and the stripe-shaped connection electrode (that is, the middle part of the high-frequency electrode). ) Has been added. The front end of the high-frequency electrode 12 is temporarily connected to the rear stripe-shaped connection electrode by the connection point, and it is ensured that the perforated wall portion of the high-frequency electrode 12 can perform the perforation; Can be separated from the striped connection electrode by the separating device and left in the lumen wall. This kind of connection method and separation device are combined into one set. Currently, connection / separation techniques that can be employed include mechanical techniques, chemical techniques (eg, ionization methods), and the like.

  In addition, in order to achieve the effect of pre- and post-surgical medication, a clinically necessary drug can be loaded on the outer surface of the high-frequency electrode 12. Specifically, a drug necessary for clinical application is applied to a clinically necessary drug on the outer surface of the high-frequency electrode, and the drug is administered to a local tissue in the process of high-frequency cauterization. As a result, drug use efficiency and clinical effects can be improved, and various complications (pain, convulsions, infection, growth, thrombosis, etc.) can be prevented and treated, and sympathetic nerve function can be regulated. If the drug for loading is loaded on the perforated wall of the high-frequency electrode, the sympathetic nerve can be adjusted. When the perforated portion of the high-frequency electrode loaded with the drug is separated and left in the lumen wall, the loaded drug can be released slowly and slowly so that it can be controlled.

  As shown in FIGS. 6 a to 8 b, the control handle 20 includes a catheter guide control handle 21, a catheter electrode control handle 23 installed at the rear end of the catheter guide control handle 21, and a catheter electrode control auxiliary handle 24. The catheter guide control handle 21 can be switched to any position between the straight position 22A and the curved position 22B as shown in FIG. 6c to control the degree of curvature of the distal end of the radiofrequency ablation catheter 10. Used to do. The degree of curvature is displayed as a degree of curvature, and the degree of curvature can be changed within a range of 0 ° to 90 °. The catheter electrode control auxiliary handle 24 can be switched to any position between an open position 25 near the catheter electrode control handle 23 and a closed position 26 far from the catheter electrode control handle 23 as shown in FIG. 6b. It is used for controlling the degree of spread of the high-frequency electrode 12 and the perforation operation of the perforation wall portion 13. Of course, the perforation operation of the perforation wall portion 13 can be controlled by switching the position of the catheter electrode control auxiliary handle 24, and an expansion / contraction controller for controlling the perforation operation of the perforation wall portion can be independently provided. Control can also be realized by installing the control handle 20. In addition, the control handle 20 is further provided with a separation controller for separating the separation device located between the high-frequency electrode 12 and the stripe connection electrode.

  As shown in FIG. 6b, when the catheter electrode control auxiliary handle 24 is switched from the closed position 26 far from the catheter electrode control handle 23 to the open position 25 close to the catheter electrode control handle 23, the high frequency electrode 12 is opened from the closed state. Switch to state. Regarding the state change between the radiofrequency ablation catheter 10 and the control handle 20, refer to FIGS. 7b and 8b, respectively. Among them, the closed state before switching is displayed with a broken line, and the extended state after switching is displayed with a solid line. Regarding the expanded state of the saddle-shaped high-frequency electrode stent displayed in the front view and the cross-sectional view, reference is made to the state indicated by the arrow 27 in FIG. 7b and the arrow 28 in FIG. 7c, respectively.

  As shown in FIG. 6c, when the catheter guide control handle 21 is switched from the straight position 22A to the curved position 22B, the distal end of the radiofrequency ablation catheter 10 is switched from the straight state to the curved state. Regarding the state change between the high-frequency ablation catheter 10 and the control handle 20, refer to FIGS. 7c and 8b, respectively. Among them, the straightened state before switching is displayed with a broken line, and the curved state after switching is displayed with a solid line. The structure of the distal end of the radiofrequency ablation catheter 10 is changed from the structure indicated by the broken line to the structure indicated by the solid line, that is, the distal end of the radiofrequency ablation catheter 10 is gradually curved from the straight state. Regarding the curved state of the radiofrequency ablation catheter 10, reference is made to the structure indicated by the arrow 29 in FIG. 6c. The catheter guide control handle 21 can be positioned at any position between the straight position 22A and the curved position 22B, and the distal end of the radiofrequency ablation catheter 10 is so close that the catheter guide control handle 21 approaches the curved position 22B. The degree of curvature increases. The curvature of the distal end of the radiofrequency ablation catheter 10 can be varied within a range of 0 ° to 90 °.

  As shown in FIG. 9, an integrated interface 50 is installed at the rear end of the control handle 20. Specifically, a circular integrated interface 50 is installed at the rear end of the catheter electrode control auxiliary handle 24. The circular integrated interface 50 includes a plurality of interfaces arranged in an annular shape, and includes a multi-channel 51 at the center of the circular integrated interface 50. A volume impedance interface 52, a temperature control interface 53, and a high frequency electrode interface 54 are installed outside the multi-channel 51, respectively. The above-described interface is used to connect the volume impedance measurement electrode, temperature measurement electrode, and high-frequency electrode in the high-frequency ablation catheter 10 to corresponding functional modules installed inside the temperature-controlled high-frequency heat condensing device 35, respectively.

  As shown in FIG. 10, in the first embodiment, the temperature control type high frequency heat condensing device 35 includes a power source and control system, a multiband volume impedance measurement module, a high frequency power generator and an automatic control module, precision measurement and temperature. A measurement module is mainly installed, and in addition, a graphical user interface is further installed. Among them, the multiband volume impedance measurement module is connected to the volume impedance measurement electrode by the volume impedance interface 52 in the integrated interface 50, and the high frequency power generator and the automatic control module are connected to the high frequency electrode by the high frequency electrode interface 54 in the integrated interface 50. The precision measurement and temperature measurement module is connected to the temperature measurement electrode by a temperature control interface 53 in the integrated interface 50.

  As mentioned above, Example 1 is demonstrated about the whole structure of the induction cautery equipment of this invention. In addition to this, in order to better realize the effect of induction cauterization and reduce the damage to the target tissue due to induction cautery, the present invention makes different improvements to the radio frequency electrode, the radiofrequency ablation catheter, and the guide catheter, respectively. . Hereinafter, the improvement will be described with reference to the drawings.

  Among them, the high-frequency electrode used in Example 2, Example 3 and Example 4 is a high-frequency electrode having three types of perforated walls, and the high-frequency electrode used in Examples 5 and 6 is a temperature. A high-frequency electrode having both a measurement function and a volume impedance measurement function. The high-frequency ablation catheter used in Example 7 and Example 8 is a high-frequency ablation catheter having a groove on its surface, and was used in Example 9. The high frequency ablation catheter is a cable type high frequency ablation catheter, and the guide catheter used in Example 10 is a guide catheter having an anti-electromagnetic interference function.

  In the prior art, percutaneous renal sympathetic nerve ablation with minimally invasive intervention technology has begun to be applied clinically and better results have been obtained. At the same time, the results of clinical studies show that there are still shortcomings of percutaneous renal sympathetic nerve ablation in the course of treatment. In percutaneous renal sympathetic nerve ablation, after inserting a high-frequency ablation catheter into the renal artery, the renal sympathetic nerve is cauterized using thermal energy converted from the high-frequency energy emitted by the high-frequency electrode. On the other hand, since the renal sympathetic nerve is located in the outermost layer of the blood vessel wall of the renal blood vessel, in the treatment process, the converted thermal energy is transmitted to each layer of the blood vessel wall of the renal blood vessel via the inner wall of the renal blood vessel, And finally it has to be transmitted to the outermost layer of the vascular wall of the renal vasculature. It was used to realize renal sympathetic nerve ablation by transferring sufficient heat energy to the outermost layer of the vascular wall of the renal blood vessels because it causes a large amount of energy loss due to heat energy transfer to the non-treatment area. The energy output and treatment time of the high frequency electrode must be increased. Therefore, it causes unavoidable damage to the blood vessel walls of the renal blood vessels. On the other hand, the blood vessel wall of the renal blood vessels is not suitable for heat energy transfer, and the blood flow velocity in the renal artery is very fast. Thereby, a large amount of heat energy is carried away by the blood stream flowing at high speed. It has a severe impact not only on the therapeutic effect of percutaneous renal sympathetic nerve ablation, but also on the effectiveness of minimally invasive interventional technology and clinical therapeutic effect.

  To this end, the present invention provides a high-frequency electrode 60 having three types of perforated walls in the second, third, and fourth embodiments. A perforated wall portion is provided at the affixing wall and high frequency energy radiation position of the high frequency electrode 60. When performing radiofrequency ablation surgery, the perforation part pierces the vascular wall directly or penetrates the vascular wall, reaches the perivascular plant plexus and radiates high frequency energy to the target lumen by high frequency ablation. Damage can be reduced to the maximum.

  The perforated wall portion installed at the position of the high-frequency electrode sticking wall / high-frequency energy radiation has a sharp acute angle at the front end, can have a blade, and has an outer shape of a cone, a rhombus, or the like. The length range of the perforated wall portion is preferably 0.01 to 20 mm, and the diameter range of the perforated wall portion is preferably 0.01 to 2.0 mm.

  The perforated wall portion mounted on the high-frequency electrode has a variety of perforated wall structures. The text exemplifies the following three types of perforated walls. Each of the three types of perforation walls is a pointed projection type perforation wall installed in the middle part of a saddle-shaped high-frequency ablation catheter, and a puncture needle type perforation wall installed at the front end of a long-puncture needle type high-frequency ablation catheter This is a puncture wall portion that is installed on the sac wall of a spherical sac-like high-frequency cautery catheter.

(Example 2)
As shown in FIGS. 11 a and 11 b, the basic structure of the saddle-shaped high-frequency electrode stent is to include a high-frequency electrode stent composed of 3 to 8 high-frequency electrodes 61. The front ends of all the high-frequency electrodes 61 are welded to a common welding point A, and constitute the front end of the high-frequency ablation catheter. The rear end of the high-frequency electrode 61 is fixed in the tube wall of the high-frequency ablation catheter. Among them, most of the high-frequency electrodes 61 are covered with an insulating layer, and only the middle portion is exposed to constitute a high-frequency energy radiation point. The high-frequency energy radiation point can be simultaneously used as a volume impedance measurement point. A pointed protrusion-type perforated wall 62 is formed at a high-frequency energy radiation point located in the middle of each high-frequency electrode 61. When the saddle-shaped high-frequency electrode stent is in a closed state, the high-frequency electrode 61 of each cage is in a straightened state, and the perforated wall portion 62 is contracted to the surface of the high-frequency electrode 61. When the saddle-shaped high-frequency electrode stent is in the stretched state, each high-frequency electrode 61 is in a curved state and protrudes outward. At the center of the high-frequency electrode 61, a pointed protrusion type wall part 62 is formed at the same time. The pointed protrusion-type wall part 62 protrudes from the surface of the high-frequency electrode 61, penetrates the blood vessel wall or penetrates the blood vessel wall, and reaches the target tissue.

  FIG. 11b is a schematic diagram showing the coronal surface presented when the saddle-like transluminal radiofrequency ablation catheter as shown in FIG. When the hook-shaped high-frequency electrode stent is in the stretched state, each high-frequency electrode 61 is in a curved state and protrudes outward. At the center of the high-frequency electrode 61, a pointed protrusion type wall part 62 is formed at the same time. The pointed protrusion type wall part 62 protrudes from the surface of the high-frequency electrode 61 and pierces the vascular intima 81 or penetrates the vascular intima 81 to reach the vascular smooth muscle layer 82 and pierces the vascular wall. Alternatively, it penetrates the blood vessel wall and directly radiates high-frequency energy to the perivascular plant plexus 83 distributed in the perivascular tissue 84 to convert it into heat energy, thereby performing nerve ablation. Thereby, the damage to the blood vessel internal tissue by high frequency cauterization can be reduced. Furthermore, in the cross-sectional view of the blood vessel shown in FIG. 11b, the portion where the blood flow in the blood vessel circulates, that is, the blood vessel wall 81 is clearly displayed. In the process of nerve ablation, the cuspid protrusion-type wall portion 62 of the high-frequency electrode 61 directly radiates high-frequency energy to the outside of the blood vessel wall, thereby avoiding the influence of blood flow in the blood vessel on the emitted high-frequency energy. . The blood flow in the blood vessel has a function of cooling the blood vessel wall. Thus, damage to the blood vessel wall due to high frequency energy radiation can be further reduced.

Example 3
As shown in FIG. 12 a, the long puncture needle type high-frequency electrode includes a support guide metal stripe 63 and a stripe puncture high-frequency electrode 64, and a perforated wall portion is provided at the front end of the stripe puncture high-frequency electrode 64. The support guide metal stripe 63 has a linear shape when stored, but is bent into an arcuate shape as shown in FIG. The front end of the support guide metal stripe 63 is fixed to the joint welding point A, and constitutes the front end of the radiofrequency ablation catheter. The rear end of the support guide metal stripe 63 is fixed in the tube wall of the radiofrequency ablation catheter.

  The striped puncture high-frequency electrode 64 includes both portions, that is, an electrode tip portion and an electrode support portion, and the electrode tip portion is an edge-type perforated wall portion installed at the front end of the stripe puncture high-frequency electrode 64 and is inserted into the blood vessel wall. it can. The electrode support portion is shown in FIG. 12 b in the state of the wall of the blade-type perforated wall portion of the stripe puncture high-frequency electrode 64. The perforated wall portion is an exposed metal and constitutes a high frequency energy radiation point. The outside of the electrode support portion is pre-coated with an insulating material. The electrode support portion is fixed to the support guide metal stripe 63. A free end is formed by the electrode tip. When the support guide metal stripe 63 is stretched and bent into an arcuate shape, the electrode tip portion protrudes from the arcuate shape, and affixing / piercing is performed.

(Example 4)
As shown in FIG. 13, the spherical sac-like high-frequency electrode includes an electrode sac 66, a perforated electrode 65, and an electrode protective shell 67, and the perforated part is a spherical sac wall outside the electrode sac 66. And constitutes a perforated electrode 65. The electrode protection shell 67 is installed outside the electrode sac 66 so as to be stretchable. The electrode sac 66 can be switched between a closed state as shown in FIG. B and an extended state as shown in FIG. The perforated electrode 65 is installed on the outer surface of the electrode sac 66. When the electrode sac 66 is in the stretched state, the perforated electrode 65 protrudes from the outer surface of the electrode sac 66, but the perforated part is inserted into the blood vessel wall (see FIG. 14). The electrode protection shell 67 is installed outside the perforated electrode 65. When the electrode sac 66 is in the closed state, the perforated electrode 65 is contracted to the outer surface of the electrode sac 66. In order to accommodate the perforated electrode 65 and the electrode ball capsule 66, the electrode protective shell 67 is closed. Thereby, it is possible to prevent unexpected damage to the blood vessel wall by the perforated electrode 65 in the process of inserting or extracting the radiofrequency ablation catheter.

  In FIG. 13, all the operations of the spherical sac-like high-frequency electrode in the spherical sac-like transluminal radiofrequency ablation catheter are simultaneously displayed. Among them, FIG. A is a schematic view showing the structure of the spherical sac-like transluminal radiofrequency ablation catheter when the electrode protective shell 67, the perforated electrode 65, and the electrode sac 66 are in a fully closed state. FIG. B is a view when the spherical sac-like transluminal radiofrequency ablation catheter exposes the walled electrode 65 and the electrode sac 66 in the closed state after the electrode protective shell 67 has been withdrawn. FIG. C is a schematic view illustrating the structure of the transluminal transluminal radiofrequency ablation catheter after the electrode protective shell 67 is retracted, and the perforated electrode 65 and the electrode spherical capsule 66 are in an open state. FIG. D is a schematic view showing the structure of the device when it is wound; FIG. D shows a spherical sac-like transluminal radiofrequency ablation catheter in which the perforated electrode 65 and the electrode sac 66 are closed again, and the electrode protective shell It is the schematic which shows the structure which had when 67 was in the middle of closing.

  After the spherical sac-like high-frequency electrode reaches the target lumen, first, the electrode protective shell 67 is withdrawn, the electrode spherical sac 66 is opened, the perforated electrode 65 is attached, and the wall is perforated; After radiating energy and finishing the process of high frequency energy radiation, the electrode sac 66 is closed, the perforated electrode 65 is contracted to the outer surface of the electrode sac 66, and the blood vessel wall is unexpectedly damaged by the perforated electrode 65. In order to prevent this, the electrode protective shell 67 is closed again;

  Each of Example 3, Example 4, and Example 5 described above is a high-frequency electrode provided with a perforated wall portion. Some of the high-frequency electrodes are deformed when actually used, and are not illustrated here.

  Hereinafter, the influence of the placement of the perforated portion on the high-frequency electrode on the high-frequency energy radiation performed in the course of nerve ablation will be described with reference to FIGS. FIGS. 15a and 15b are schematic views showing the contrast between the thermal energy transfer of the prior art and the thermal energy transfer of the high-frequency electrode having the perforated wall portion of the present invention.

  The area 91 of thermal energy distribution in the single-point high-frequency electrode and the direction 92 of heat energy transfer in the blood flow are clearly shown in FIGS. 15a and 15b, respectively. Among them, the intraluminal high-frequency energy radiation point is located at the center of blood flow. Most of the thermal energy transmitted by the high-frequency electrode is directly carried away by the blood flowing at high speed, and only the remaining thermal energy is transmitted to the surrounding blood vessel 84 via the blood vessel wall.

  The transluminal radiofrequency ablation of the present invention refers to the area 95 of the thermal energy distribution in the high frequency electrode with the perforated wall in FIG. 15b for the position of the high-peripheral energy radiation in the transluminal radiofrequency ablation. To do. Since the perforated wall portion is installed on the high-frequency electrode, the high-frequency energy radiation point is propelled from the lumen of the blood vessel to the inside of the blood vessel wall, causing a fundamental change in heat energy transfer as described below. 1. By embedding a high-frequency electrode in the blood vessel wall and performing intraluminal high-frequency cauterization, the high-frequency electrode is more effectively brought close to the perivascular plant plexus, and the heat energy transmitted by the high-frequency electrode is transferred to the blood vessel wall. The transmission distance and time are significantly shortened, and the range in which the thermal energy is transferred into the tissue of the blood vessel wall is simultaneously reduced, improving the therapeutic effect and at the same time reducing the damage to the blood vessel wall caused by high frequency energy radiation. 2. The high frequency electrode transfers thermal energy into the vessel wall, eliminating the negative effects of blood flow in the cavity quickly carrying away the thermal energy. Furthermore, the present invention recognizes and utilizes fast flowing blood flow to carry away the thermal energy of the inner wall of the blood vessel, providing more effective protection for the blood vessel wall, while at the same time accumulating the thermal energy of the outer blood vessel wall. Will not be affected. Clinically, less radio frequency energy and shorter time can be used to achieve the therapeutic effect and make the treatment more effective.

  The induction cautery equipment of the present invention has been described above. Hereinafter, transluminal transmural sympathetic radiofrequency ablation will be described as an example of percutaneous transrenal artery transmural sympathetic radiofrequency ablation.

  First, a blood vessel is punctured and a vascular sheath is embedded by the Seldinger method. A guiding catheter is inserted into the renal artery via the vascular sheath and a transluminal radiofrequency ablation catheter is further inserted from the posterior end interface of the guiding catheter. When the distal end (ie, the far end) of a transluminal radiofrequency ablation catheter is inserted into the renal artery, the volume impedance monitoring and measurement system is activated and the volume impedance electrode measures the volume impedance of the lumen prior to surgery. To determine the ideal ablation area or ablation point. When the ablation area is determined, the high-frequency electrode is affixed by the controller of the control handle, that is, the high-frequency electrode is brought close to the inner wall of the lumen that is the ablation site; Proceed and perform a piercing operation, that is, puncture the piercing wall portion at the front end of the high-frequency ablation catheter to the luminal wall through the lumen. In addition, the puncture depth is controlled and selected according to clinical demand, and in order to ensure the completeness and sealing of the blood vessel wall, the permissible range allows the high frequency electrode to be as close as possible to the target tissue, that is, the nerve that must be cauterized. Is within. When the perforated wall reaches a preset puncture depth, it activates a high-frequency ablation system capable of temperature control. The high-frequency energy radiated by the high-frequency ablation system is sequentially transmitted from the high-frequency electrode to the perforation part and the vascular tissue, converted into thermal energy, and absorbed by the tissue surrounding the blood vessel, thereby causing a cauterization action on the surrounding nerves. Uses high-frequency electrodes with perforated walls, so there is less high-frequency energy demand to achieve clinical therapeutic effects than in the prior art, shorter time and less local damage to the lumen wall And the perforation wall forms a fibrotic scar around the puncture needle path, thereby self-sealing the puncture needle path and ensuring completeness and sealing in the lumen.

  In the process of high-frequency cauterization, the volume impedance monitoring measurement system is activated in real time or discontinuously to determine whether or not to continue or stop high-frequency cauterization and monitor the volume impedance in the cauterization area. Measure. When the degree of nerve ablation satisfies clinical requirements, it stops high frequency energy radiation. Thereafter, the high-frequency electrode provided with the perforated wall is pulled back into the lumen by the controller of the control handle and contracted into the high-frequency ablation catheter. Thereafter, the radiofrequency ablation catheter is removed and the operation is completed.

  In order to perform renal sympathetic nerve radiofrequency ablation that is more effective and safe when performing clinical treatment, the present invention is a high-frequency electrode stent that can perform drug loading and local implantation, except for the above steps. Provide further. When the degree of nerve ablation satisfies clinical requirements, it stops high frequency energy radiation. Thereafter, the separation device located between the high-frequency electrode 12 and the stripe-shaped connection electrode is separated by the separation controller of the control handle, and the high-frequency electrode is left in the lumen wall. Thereafter, the radiofrequency ablation catheter is removed and the operation is completed. A clinically necessary drug is loaded on the outer surface of the high-frequency electrode, and the loaded drug is released in the process of high-frequency cauterization. Thereby, the utilization efficiency and clinical effect of the drug can be improved, and the occurrence of various complications (pain, convulsions, infection, growth, thrombosis, etc.) can be prevented and treated. When the perforated portion of the high-frequency electrode loaded with the drug is separated and left in the lumen wall, the loaded drug can be released slowly and slowly. Thereby, the regulation of the sympathetic nerve is realized.

(Example 5)
In the high-frequency ablation equipment of the present invention, the high-frequency electrode is an important part for contacting or approaching the treated human tissue and emitting high-frequency energy. The high-frequency electrode is used to radiate high-frequency energy and convert it into heat energy, and uses the heat energy to treat human tissue.

  In order to realize real-time monitoring measurement in the process of high-frequency energy radiation, the present invention provides a high-frequency electrode capable of simultaneously performing high-frequency energy radiation, volume impedance measurement, and temperature measurement. The basic function of the high frequency electrode is high frequency energy radiation. By measuring the volume impedance of the high frequency energy radiation point of the high frequency electrode, the volume impedance measurement function can be realized. A second material is bonded to the high frequency electrode. The second material is a material different from the material for constituting the high-frequency electrode. Therefore, a thermocouple for measuring temperature is composed of a high-frequency electrode and a second material. The temperature measurement can be realized by measuring the current flowing through the bonding interface located between the high-frequency electrode and the second material. In order to improve the accuracy of temperature control in the process of high-frequency cautery surgery, the joint where the second material is bonded to the high-frequency electrode is installed in the vicinity of the high-frequency energy radiation point.

  The high-frequency electrode as shown in FIG. 16 is a saddle-shaped high-frequency electrode stent that can simultaneously realize three types of functions. In this embodiment, the saddle-like high-frequency electrode stent made of nickel-titanium alloy is made up of 3 to 8 high-frequency electrodes 101. The front ends of all of the high-frequency electrodes 101 are welded to a common welding point A to constitute the front end of the high-frequency ablation catheter. The rear end of the high-frequency electrode 101 is fixed in the tube wall of the high-frequency ablation catheter. Among them, most of the high-frequency electrode 101 is covered with an insulating layer, and only the middle part is exposed to constitute a high-frequency energy radiation point. The high-frequency energy radiation point can be simultaneously used as a volume impedance measurement point. A second material 102 copper-zinc alloy is locally joined to the high-frequency electrode 101. A joint located between the high-frequency electrode 101 and the second material 102 copper-zinc alloy is installed in the vicinity of the high-frequency energy radiation point. As shown in FIG. 16, in this embodiment, the copper-zinc alloy is joined to the front end of the high-frequency electrode 101 nickel-titanium alloy, at a position close to the joint welding point A. When the temperature was measured, the current flowing through the bonding interface B (the area indicated by the arrow in the circle indicated by the dotted line in FIG. 16) located between the nickel-titanium alloy and the copper-zinc alloy was The temperature value can be obtained through measurement and calculation.

  The shape of the saddle-shaped high-frequency electrode stent made of a nickel-titanium alloy can be restored to a molded shape, that is, a rugby football shape, at body temperature. Thereby, the high-frequency electrode of the saddle-shaped high-frequency electrode stent is stuck. A guide catheter is installed outside the ablation catheter. When a high-frequency ablation operation is performed, first, the front end of the guide catheter is inserted into the target lumen. Thereafter, the induction cautery catheter is further inserted into the guide catheter. At this time, the saddle-shaped high-frequency electrode stent 101 is limited by the ablation catheter, is compressed into the guide catheter, and is pushed to the front end of the guide catheter. After the hook-shaped high-frequency electrode stent 101 is exposed from the guide catheter, the shape of the hook-shaped high-frequency electrode stent begins to be restored to the shape formed by body temperature. After completing the radiofrequency ablation surgery, the radiofrequency ablation catheter is pulled back into the guiding catheter. The saddle-shaped high-frequency electrode stent is restricted by a high-frequency ablation catheter and is compressed into a rod-like shape and pulled out of the body as it is.

  In the fifth embodiment, the high-frequency electrode 101 is connected to the temperature-controlled high-frequency heat condensing device 35 by the effect line 104 and the common ground line 103. In addition, the high-frequency electrode 101 and the second material 102 are each connected to a conductive wire, and further connected to the temperature data collection module in the temperature-controlled high-frequency heat condensing device 35 by the conductive wire. The induced current flowing through the measurement circuit is measured, and the temperature measurement is realized through calculation.

  As described above, the shape of the saddle-shaped high-frequency electrode stent is body temperature and can be restored to a molded shape, that is, a rugby football shape. Thereby, the high-frequency energy radiation point of the saddle-shaped high-frequency electrode stent is attached to the inner wall of the blood vessel. Among them, most of the nickel-titanium alloy is covered with an insulating layer (for example, polytetrafluoroethylene), and only the partially exposed metal point A constitutes a high-frequency energy radiation point. The high-frequency energy radiation point can be simultaneously used as a volume impedance measurement point. In this embodiment, a temperature sensor made of a copper-zinc alloy is joined to a nickel-titanium alloy by a welding method by applying the thermocouple principle. Furthermore, the temperature measurement is performed by measuring different currents generated as the temperature of the metal interface formed from the nickel-titanium alloy and the copper-zinc alloy changes. Since the exposed nickel-titanium alloy itself has an electrical resistance measurement function, it is possible to directly measure the electrical resistance of the human body using a measurement circuit composed of high-frequency electrodes. However, when measuring the electrical resistance of the human body, the electrical resistance measurement error caused by the current due to the temperature of the metal interface must be corrected.

(Example 6)
The long puncture needle type high-frequency electrode capable of realizing three types of functions simultaneously refers to FIG. 17a for the closed state and FIG. 17b for the extended puncture state.

  The long puncture needle type high-frequency electrode as shown in FIG. 17a includes a support guide metal stripe 110, a puncture high-frequency electrode 111, a second material 112 joined to the puncture high-frequency electrode 111, a common ground line 113, an effect line 114, and expansion / contraction control. Includes line 115.

  Among them, the support guide metal stripe 110 has a linear shape as shown in FIG. 17a when closed, but is bent into an arcuate shape as shown in FIG. 17b when stretched. The front end of the support guide metal stripe 110 is fixed to the joint welding point A and constitutes the front end of the radiofrequency ablation catheter. The rear end of the support guide metal stripe 110 is fixed in the tube wall of the radiofrequency ablation catheter.

  The puncture high-frequency electrode 111 includes both portions, that is, an electrode tip portion 111A and an electrode support portion 111B. In the embodiment as shown in FIG. 17a, the electrode tip portion 111A is an exposed metal and constitutes a high-frequency energy radiation point. The electrode tip portion 111A is also a perforated wall portion of the puncture high-frequency electrode 111, and the outside of the electrode support portion 111B is covered in advance with an insulating material. The electrode support portion 111B is fixed to the support guide metal stripe 110. The electrode tip portion 111A forms a free end. When the support guide metal stripe 110 is stretched and curved into an arcuate shape, the electrode tip portion 111A protrudes from the arcuate shape and contacts the vascular endothelium.

  A second material 112 is bonded to the puncture high-frequency electrode 111. The second material 112 is bonded in the vicinity of the electrode tip portion 111A of the puncture high-frequency electrode 111 and is close to the high-frequency energy radiation point. When the puncture high-frequency electrode 111 radiates high-frequency energy, thermal energy converted from the radiated high-frequency energy causes a temperature change in the vicinity of the puncture high-frequency electrode 111. At that time, a potential difference exists at the bonding interface located between the puncture high-frequency electrode 111 and the second material 112. A current flowing through a bonding interface located between the puncture high-frequency electrode 111 and the second material 112 is measured, and a temperature value is obtained through calculation.

  Needless to say, the puncture high-frequency electrode 111 can be provided with a high-frequency energy radiation point on the electrode support portion 111B except for the electrode tip portion 111A. Therefore, the second material 112 can also be installed on the electrode support portion 111B of the puncture high-frequency electrode 111 at different installation positions with different high-frequency energy radiation points.

  In the puncture high-frequency electrode, the support guide metal stripe 110 is made of a non-memory alloy. In order to realize the stretching of the support guide metal stripe 110, an expansion / contraction control line 115 is provided on the stripe puncture high-frequency electrode. The front end of the expansion / contraction control line is fixed to a joint welding point located on the high-frequency electrode, and the rear end (that is, the proximal end) of the expansion / contraction control line 115 is connected to the control handle through the high-frequency ablation catheter. During use, the support guide metal stripe 110 is stretched by pulling the expansion / contraction control line 115.

  The expansion / contraction control line 115 is made of a metal wire having a certain hardness. The radiofrequency ablation catheter can be pushed forward by pushing the telescopic control line 115 forward by the control handle. The forward movement of the high-frequency ablation catheter pulls the expansion / contraction control line 115 to contract the support guide metal stripe 110. The contracted state of the support guide metal stripe 110 is advantageous for inserting the radiofrequency ablation catheter into the target lumen. When the high-frequency ablation catheter reaches the target lumen, the telescopic control line 115 is pulled backward by the control handle, thereby pulling the front end of the high-frequency ablation catheter and changing the state of the support guide metal stripe 110 from the contracted state to the expanded state. You can force it to change. At this time, the support guide metal stripe 110 protrudes outward, and the puncture high-frequency electrode 111 of the long puncture needle type high-frequency electrode is attached to create a condition for high-frequency cauterization. After the operation is completed, the support guide metal stripe 110 is contracted by pushing the control handle forward to smoothly extract the radiofrequency ablation catheter.

  In this embodiment, the puncture high-frequency electrode 111 is connected to the temperature-controlled high-frequency heat condensing device 35 by an effect line 114 and a common ground line 113. The puncture high-frequency electrode 111 and the second material 112 are each connected to a conductive wire, and further connected to the temperature data collection module in the temperature-controlled high-frequency heat condensation apparatus 35 by the conductive wire. The induced current flowing through the measurement circuit is measured, and the temperature measurement is realized through calculation.

  In summary, the high-frequency electrodes in Example 5 and Example 6 were able to simultaneously realize three types of functions, that is, a high-frequency energy radiation function, a temperature measurement function, and an electrical resistance measurement function. Specifically, the high-frequency electrode itself has a high-frequency energy radiation function and an electrical resistance measurement function, but a temperature measurement function is realized by forming a thermocouple by joining the high-frequency electrode to a second material by a welding method. I am letting. By configuring the high-frequency ablation system using the high-frequency electrode, the temperature sensor and the electrical resistance sensor installed in the vicinity of the high-frequency electrode are omitted, and the flexibility in use of the entire high-frequency electrode is improved. The process of induction cauterization can be easily controlled.

  In particular, in Example 5, a nickel-titanium alloy is used to construct a thermocouple. Since the nickel-titanium alloy is a memory alloy, its shape can be restored to its original shape at an appropriate temperature. For example, the shape of the nickel-titanium alloy can be restored to its original shape at body temperature. For example, the shape of a nickel-titanium alloy can be restored to an arcuate shape at body temperature. Thereby, contact / bonding of the high-frequency electrode 101 and the second material 102 is realized. Therefore, in Example 5, there is no need to install an expansion / contraction control line for pulling the high-frequency electrode and deforming it, and the configuration of the high-frequency electrode is simplified. Of course, the high-frequency electrode 101 can be made of another memory alloy. For example, the high-frequency electrode 101 can be made of a copper-nickel alloy or a titanium alloy. When the high-frequency electrode is made of a memory material other than the memory alloy, only the expansion / contraction control line for pulling the high-frequency electrode to protrude may be provided. Regarding the installation method of the expansion / contraction control line, refer to the installation of the expansion / contraction line in Example 6. Therefore, the material for constituting the high-frequency electrode 101 of the present invention is not limited by the memory alloy, and the high-frequency electrode 101 may be constituted only by a stretchable material. For example, the high frequency electrode 101 may be made of an alloy other than the memory alloy or a metal. Similarly, in the above embodiment, a copper-zinc alloy is joined as a second material to a nickel-titanium alloy to constitute a thermocouple for measuring temperature. Of course, other materials can be used as the second material. For example, a pure copper alloy, a platinum alloy, or chromel can be used as the second material 102. The second material 102 is a material different from the material for constituting the high-frequency electrode.

  Similarly, the high-frequency electrode is not limited by the shape of the high-frequency electrode in the embodiment, and except for the saddle-shaped high-frequency electrode stent in the fifth embodiment and the long puncture needle-type high-frequency electrode in the sixth embodiment, It can also be formed into a shape. That is, the shape of the high frequency electrode has no effect on the simultaneous realization of the three functions. During actual use, the high frequency electrode can be formed in any conventional shape other than the shape of the high frequency electrode of the present invention.

  The structure of the high-frequency electrode of the present invention having both a temperature measurement function and an electrical resistance measurement function will be described using Example 5 and Example 6, in which the second material is bonded to the high-frequency electrode. That is mentioned. Among them, with respect to the installation method of the second material, bonding can be realized by selectively using a plurality of installation methods. For example, the joining can be realized by selecting and using any one of a welding method, a plating method, an insertion method, and a pressure bonding method. Of course, other types of bonding methods not exemplified here are also included.

  In order to ensure temperature measurement accuracy, the bonding performance related to the bonding between the second material 102 and the high-frequency electrode 101 must satisfy higher requirements. For example, when the welding is realized using the welding method, the second material 102 and the high-frequency electrode 101 may be welded using the pressure welding method in order to ensure the cleanliness of the welding surface. it can. Hereinafter, another bonding method will be described with reference to FIGS. 18a to 18c. Among them, as shown in FIG. 18a, first, the base material 101a on the high-frequency electrode 101 is removed. Thereafter, the second material 102 is grown to the original position where the portion of the base material in the high-frequency electrode 101 is removed. As shown in FIG. 18 b, the second material 102 is joined to the high-frequency electrode 101 by the joint tool 120 and is in close contact with the high-frequency electrode 101 inside the joint tool 120. As shown in FIG. 18 c, first, the second material 102 is wound around the high-frequency electrode 101. Thereafter, the second material 102 is covered with a metal ring 102 '. Finally, the metal ring 102 ′ is pressure-bonded to the second material 102 with an external force, and the second material 102 is bonded to the high-frequency electrode 101. Example 10 is referred to for an example for forming a high-frequency electrode having both a temperature measurement function and an electrical resistance measurement function by a crimping method and a manufacturing method thereof. Detailed description will not be repeated here. The bonding method for bonding the second material to the high-frequency electrode is not restricted by the four types of bonding methods exemplified above.

  The high frequency electrode of the present invention has been described above. Hereinafter, the structure and measurement principle of the temperature-controlled high-frequency heat condensing device connected to the high-frequency electrode will be described with reference to FIGS. 19 to 26a.

  As shown in FIG. 19, the temperature-controlled high-frequency heat condensing device includes a sine wave generation module 121, a signal multiplication module 122, a power amplification module 123, a switch module 124, a high-frequency electrode module, a central processing unit 129, an output voltage / current. A monitoring measurement module 130, a temperature data collection module 131, a data display module 132, and a control module 133 are included.

  Among them, the sine wave generation module 121, the data display module 132, and the control module 133 are each connected to the central processing unit 129, and the high frequency electrode module is connected to the central processing unit 129 via the switch module 124 to generate a sine wave. The module 121, the signal multiplication module 122, the power amplification module 123, and the switch module 124 are sequentially connected to the high frequency electrode module, and the output voltage / current monitoring measurement module 130 is connected to the central processing unit 129 and the power amplification module 123, respectively. The temperature data collection module 131 is connected to the central processing unit 129 and the switch module 124, respectively.

  In the temperature control type high-frequency heat condensing device, the central processing unit 129 is used for controlling the switching of the operation mode of the switch module 124, and the central processing unit 129 is a sine wave having a different sine wave generation module 121. The central processing unit 129 is used to control the generation of the output voltage / current monitoring and measurement module 130, the data collection operation of the temperature data collection module 121, and the data display module 132 displays the data. Is used to control that. The data display module 132 displays the high-frequency parameters and various monitoring measurement results. The control module 133 includes adjustment keys and push buttons, and circuits corresponding to the keys and push buttons. The control module 133 is connected to the central processing unit 129. The central processing unit 129 can adjust parameters related to the process of high-frequency cauterization by controlling the control module 133.

  The temperature-controlled high-frequency heat condensing device has three types of operation modes. The central processing unit 129 controls the switch module 124 to switch the operation mode to any one of the three operation modes. At the same time, the central processing unit 129 controls the sine wave generation module 121 to generate a sine wave having a frequency corresponding to the operation mode. The generated sine wave is signal-multiplied by the signal multiplication module 122, power-amplified by the power amplification module 123, and transmitted to the high-frequency electrode 126 via the switch module 124. Further, when the switch module 124 switches the operation mode to the electric resistance measurement operation mode, the output voltage / current monitoring measurement module 130 measures the current and voltage output by the power amplification module 123 and performs a central processing unit. However, when the switch module 124 switches the operation mode to the temperature measurement operation mode, the temperature data collection module 131 measures the current flowing through the high-frequency circuit and calculates the temperature data calculated through the calculation. Return to the processing unit 129.

  As shown in FIG. 19, in this embodiment, the switch module 124 includes three switches S1, S2, S3 installed in parallel. The high-frequency electrode module includes three high-frequency electrodes 126, a thermocouple composed of the high-frequency electrode 126 and a second material, and a body surface electrode 128. The three switches S1, S2, and S3 are connected to the high-frequency electrode conductor 125, the thermocouple conductor 127, and the body surface electrode conductor 128, respectively, to realize switch-on. The high frequency electrode conducting wire 125 is simultaneously a thermocouple conducting wire. The high frequency electrode conducting wire 125 and the thermocouple conducting wire are connected to the second material joined to the high frequency electrode 126 and the high frequency electrode 126, respectively. When the switches S1 and S2 of the switch module 124 are switched on, the high-frequency electrode 126 and the second material joined to the high-frequency electrode 126 form a thermocouple measurement circuit. When the switches S1 and S3 of the switch module 124 are switched on, the high frequency electrode 126 and the body surface electrode 128 form a high frequency energy radiation circuit. The high-frequency energy radiation circuit is simultaneously used as a temperature measurement circuit. Two types of operation modes: In the high-frequency energy radiation operation mode and the electrical resistance measurement operation mode, the frequency of the sine wave generated by the sine wave generation module 121 is not the same. In the case of the high-frequency energy radiation operation mode, the frequency of the sine wave is 465 kHz. In the case of the electric resistance measurement operation mode, the frequency of the sine wave is 50 kHz or 100 kHz.

  In the electric resistance measurement operation mode, as shown in FIG. 20, the sine wave generation module 121 generates a sine wave. The generated sine wave is multiplied by a signal multiplication module 122, amplified by a power amplification module 123, and transmitted to a human body electrical resistance 134 via a switch module 124 and further via a high frequency electrode 126. At this time, first, the sine wave generation module 121 generates a sine wave having a frequency of 50 KHZ and a power of 1 W, and the central processing unit 129 emits high frequency energy radiation measured by the output voltage / current monitoring measurement module 130. Based on the voltage and current before and after, the electrical resistance 134 of the human body is calculated. Thereafter, the sine wave generation module 121 generates a sine wave having a frequency of 100 KHZ and a power of 1 W, and the central processing unit 129 measures the voltages before and after the high frequency energy emission measured again by the output voltage / current monitoring measurement module 130, respectively. The electric resistance 134 of the human body is calculated again based on the current and the current. Finally, the average value of the electrical resistance 134 of the human body is calculated from the calculated value of the electrical resistance 134 of the human body in these two cases, and the measurement result of the electrical resistance 134 of the human body is obtained.

  In the temperature measurement operation mode, when the switch S3 of the switch module 124 is switched on and the switches S1 and S2 are switched on, the high-frequency electrode conductor 125 and the thermocouple conductor 127 are switched on by the switches S1 and S2, respectively. The high-frequency electrode conductor 125 is simultaneously used as a thermocouple conductor. Therefore, the high-frequency electrode conducting wire 125, the thermocouple conducting wire 127, and the thermocouple composed of the second material and the high-frequency electrode 126 form a circuit. The temperature data collection module 131 collects current data relating to the current flowing through the circuit, and calculates the temperature of the thermocouple measurement point based on the change in the current. As shown in FIG. 21, in the temperature measurement process, the contact point A formed by joining two different materials is the hot end of the thermocouple, but the point B far from the high frequency electrode is the cold end of the thermocouple (see Also called end). When the temperature at point A changes, an electromotive force and an induced current are generated in a closed loop of the thermocouple. Since the ambient temperature is changing, the reference temperature is not a standard absolute temperature. Therefore, as shown in FIG. 21, a temperature compensation circuit of a bridge circuit is connected in parallel to the cold end B of the thermocouple to perform temperature compensation. When the environmental temperature changes, the electric resistance value of the thermistor R0 also changes. The temperature change is directly proportional to the electromotive force. At this time, the electromotive force generated when the temperature at the hot end A of the thermocouple is changed is amplified by a differential amplifier circuit, then converted into a digital value through AD conversion, and the digital value is displayed.

  Regarding the operation mode of high-frequency energy radiation, the operation mode of high-frequency energy radiation is divided into two types of operation modes, that is, operation mode 1 and operation mode 2. The operation mode 1 is a high-frequency energy radiation operation mode in which a circuit is constituted by a single high-frequency electrode and a body surface electrode used in the above-described embodiment, but the operation mode 2 is constituted by a dual-frequency electrode. This is an operation mode of high-frequency energy radiation. Hereinafter, the operation modes of these two types of high-frequency energy radiation will be described with reference to FIGS. 22a and 22b.

  In operation mode 1, as shown in FIG. 22a, each high frequency electrode 126 and body surface electrode 128 constitute one circuit. A sine wave having a frequency of 465 kHz generated by the sine wave generation module 121 during high-frequency energy radiation is multiplied by the signal multiplication module 122, amplified by the power amplification module 123, and switched on by the switch S1, It is transmitted to a high frequency energy radiation point on the high frequency electrode 126 by a conducting wire. At this time, the high-frequency electrode 126, the electric resistance 134 of the human body, and the body surface electrode 128 constitute one circuit. Based on the output voltage and current measured by the output voltage / current monitoring measurement module 130, the radiated high frequency energy can be calculated.

  In the operation mode 2, as shown in FIG. 22b, one high frequency electrode 126 constitutes one circuit. A sine wave having a frequency of 465 kHz generated by the sine wave generation module 121 during high-frequency energy radiation is multiplied by the signal multiplication module 122, amplified by the power amplification module 123, and switched on by the switch S1, It is transmitted to a high frequency energy radiation point on the high frequency electrode 126 by a conducting wire. At this time, a circuit is constituted by two high-frequency electrodes 126 and the electrical resistance 134 of the human body. Based on the output voltage and current measured by the output voltage / current monitoring measurement module 130, the radiated high frequency energy can be calculated.

  As described above, the high-frequency electrode having both the temperature measurement function and the electric resistance measurement function is used to configure a thermocouple by bonding the high-frequency electrode to the second material to measure the temperature, and at the high-frequency energy radiation point itself. High-frequency energy radiation and electrical resistance measurement are also performed. Thereby, a high frequency energy radiation function, a temperature measurement function, and an electrical resistance measurement function can be realized simultaneously. The construction of a high-frequency ablation system using the high-frequency electrode can omit the temperature sensor and the electrical resistance sensor installed in the vicinity of the high-frequency electrode, and improves the flexibility in use of the entire high-frequency electrode. It becomes easy to control the process of shochu. In addition, the use of the high frequency electrode can improve the measurement accuracy of temperature and electrical resistance.

  When using a temperature-controlled high-frequency heat condensing device, monitoring and measuring the electrical resistance at the high-frequency energy radiation point and the temperature in the vicinity of the high-frequency energy radiation point provides data for reflecting the state of high-frequency cauterization in the lumen. Return to the central processing unit in the temperature-controlled high-frequency heat condensation equipment. It is convenient for the surgeon to grasp the process of induction and adjust the parameters.

(Example 7)
In general, a high-frequency ablation catheter establishes a path from the outside of the body to the heart or the renal artery in cooperation with the guide catheter, and most of the high-frequency ablation catheter must be held inside the guide catheter. That is, the outer wall of the high-frequency ablation catheter is covered with the guide catheter during the high-frequency ablation operation. Therefore, the inner diameter of the guiding catheter must be larger than the inner diameter of the high-frequency ablation catheter. Thereby, the high-frequency ablation catheter can be smoothly penetrated into the guide catheter. In addition, during a high-frequency ablation operation, a DSA contrast facility must be used in order to clearly see the decisive situation such as the shape, position, and size of a target lumen such as a blood vessel. Therefore, the contrast agent must be injected into the guiding catheter. In addition, physiological saline for labration and heparin for anticoagulation must also be injected into the guiding catheter during high-frequency ablation surgery. Therefore, in order to satisfy the requirements for contrast, labration, anticoagulation, etc. in radiofrequency ablation surgery, radiofrequency ablation catheters and guides are premised on the assumption that they will not be adversely affected by the basic function and strength of radiofrequency ablation catheters. A gap must be formed between the catheter and the catheter.

  In the prior art, a high-frequency ablation catheter is manufactured from a circular tube, and the conductor and other components are installed inside the circular tube. In order to create a gap between the radiofrequency ablation catheter and the guide catheter, the inner diameter of the guide catheter must be increased. Therefore, it increases the difficulty of radiofrequency ablation surgery. In addition, in order to smoothly penetrate the high-frequency ablation catheter into the guide catheter, the frictional force generated between the high-frequency ablation catheter and the guide catheter must be reduced. Therefore, there is also a need to provide a high-frequency ablation catheter that has a reduced contact area when the high-frequency ablation catheter is passed through the guide catheter.

  As shown in FIGS. 23 to 25, the radiofrequency ablation catheter 210 having a groove on its surface includes a support catheter 201 disposed in the center and a plurality of conductors 202 disposed on the outer surface of the support catheter 201. The plurality of conducting wires 202 are arranged along the circumferential direction of the support catheter 201, and each conducting wire 202 is extended along the length direction of the supporting catheter 202, and the conducting wire is connected to the outside of each conducting wire 202. A sealing layer 203 for covering 202 is disposed, and adjacent sealing layers 203 form grooves on the outer surface of the support catheter 201.

  In the high-frequency catheter 210 having a groove as Example 7, as shown in FIG. 24a, the six conducting wires 202 are evenly arranged along the circumferential direction of the outer periphery of the circular support catheter 201, and mutually correspond to each other. The two connecting lines formed by connecting the centers of the two adjacent conducting wires 202 with the center of the supporting catheter 201 form a 60 ° included angle, and thus the six conducting wires 202 are formed on the supporting catheter 201. It is distributed and formed in a shape like plum blossoms along the outer peripheral direction, and a sealing layer 203 for covering the conductive wire 202 is arranged outside the conductive wire 202 to constitute a high-frequency ablation catheter 210, which has a groove. The cross-sectional shape of the high-frequency ablation catheter 210 also has a plum-like shape, the cross-sectional shape of the sealing layer 203 coated on the outside of the single conducting wire 202 has an arc shape, and the bottom of the sealing layer 203 The outer surface of the support catheter 201 is tightly joined to form an arc-shaped space, and the conductive wire 202 is disposed in the arc-shaped space. At the same time, the adjacent sealing layer 203 is grooved on the outer surface of the support catheter 201. Is forming.

(Example 8)
In the high-frequency catheter 210 having a groove as Example 8, as shown in FIG. 24b, the arrangement method and the number of arrangement for arranging the conducting wire 202 along the circumferential direction of the outer periphery of the support catheter 201 are examples. The same as 7 but with the following differences. The cross-sectional shape of the sealing layer 203 coated on the outside of the single conductive wire 202 is not the same as that of the seventh embodiment. In Example 8, the cross section of the sealing layer 203 is composed of an arc-shaped top portion and linear side walls that are connected to the bottom of the arc-shaped top portion and extend to the outer surface of the support catheter 201. The top portion of the shape, the side wall of the straight shape, and the outer surface of the support catheter 201 form a sealed space, and the six conductors 202 are arranged in independent sealed spaces.

  In Example 7 and Example 8, the radiofrequency ablation catheter 210 having a groove on the surface includes six conductors 202, and the sealing layers 203 coated on the outside of the conductors 202 are independent from each other and are not in contact with each other. However, as the number of the conductive wires 202 increases or as the contact area of the contact surface where the sealing layer 203 is not tightly joined to the support catheter 201 increases, the adjacent sealing layers 203 are integrally connected, and the support catheter The entire outer surface of 201 can be coated. That is, the sealing layers 203 can be independent from each other, and can be integrally connected to form the entire sealing layer.

  In order to improve the strength and toughness of the radiofrequency ablation catheter 210 having grooves on its surface, the sealing layer 203 can be manufactured using a polymer material. For example, any one of polyurethane, polyethylene, polypropylene, and nylon can be used. When the radiofrequency ablation catheter 210 is manufactured, if the sealing layer 203 covering the outside of the different conductors is already integrated, a polymer material having the same thickness is thermally welded to the outside of the conductor 202 to seal the sealing layer 203. Can be manufactured,

  The high-frequency ablation catheter 210 having a groove on the surface has a small volume and a small size. In order to further reduce the volume of the radiofrequency ablation catheter 210 with grooves on the surface, the conductor 202 can be in direct contact with the outer surface of the support catheter 201, but the conductor 202 is tangent to the top of the sealing layer 203. You can also. That is, in the high-frequency ablation catheter 210 having a groove on the surface, the conducting wire 202 is tangent to the outer surface of the support catheter 201, and the conducting wire 202 is also tangent to the top portion of the sealing layer 203.

  When the high-frequency ablation operation is performed, as shown in FIG. 25, the high-frequency ablation catheter 210 having a groove on the surface thereof penetrates the guide catheter 220, and with the cooperation of the guide catheter 220, the heart or the renal artery from outside the body. You have to build a route to In addition, the configuration of a guide catheter 220 having an anti-electromagnetic interference function is also shown in FIG. The installation of a shielding net inside the guide catheter 220 will be described in detail using Example 10.

  Hereinafter, the use situation of the high-frequency ablation catheter 210 having a groove on the surface and the gap between the high-frequency ablation catheter 210 having a groove on the surface and the guiding catheter will be described with reference to FIG. 26a. 26a and 26b, a high-frequency ablation catheter 210 having a groove on the surface thereof is compared with a conventionally used cylindrical high-frequency ablation catheter 210 '.

  In the prior art cylindrical high-frequency ablation catheter 210 ', the high-frequency ablation catheter 210' is made of a circular tube, and the conductor and other components are installed inside the circular tube. Induction cautery catheter 210 'has a cylindrical shape with a smooth outer surface. As shown in FIG. 26 b, when the cylindrical high-frequency ablation catheter 210 ′ passes through the guide catheter 220, the entire cylindrical outer surface may contact the inner surface of the guide catheter 220. The area is relatively large. On the other hand, as shown in FIG. 26a, in the high-frequency ablation catheter 210 provided with a groove on the surface, only the top portion of the sealing layer 203 is guided when the high-frequency ablation catheter 210 provided with the groove is passed through the guide catheter 220. There is a possibility of contact with the inner surface of the catheter 220, the contact area is greatly reduced, the frictional force is reduced, and it is convenient for performing high-frequency ablation surgery.

  Further, the gap between the induction catheter 210 having a groove on the surface and the guide catheter 220, which is known from a comparison between FIG. 26a and FIG. 26b and exists in the guide catheter 220 having the same tube diameter, is as follows. Even bigger. The gap distributed on its outer surface can be increased by a factor of more than the gap between the prior art radiofrequency ablation catheter 210 ′ and the guide catheter 220. In addition, by effectively using the gap between the high-frequency ablation catheter 210 and the guide catheter 220, it is possible to satisfy the requirements for contrast, labration, anticoagulation, and the like in the high-frequency ablation operation. The gap can accommodate more contrast agent, increase the contrast effect, acquire a large space for the labment, improve the guide catheter labment effect, more heparin etc. The anticoagulant drug can be housed to exert an anticoagulant action.

  In summary, a high-frequency ablation catheter having a groove on its surface has a plurality of conductors installed on the outer surface of the support catheter. A plurality of grooves can be formed in the outer surface of the radiofrequency ablation catheter by sealing each conductor using different sealing layers. Compared to the design in the prior art where the lead wire and other parts are installed inside a circular tube, the contact area when the outer surface of a high-frequency ablation catheter with grooves on the surface contacts the inner wall of the guide catheter is It is even smaller and the frictional force is greatly reduced, which is convenient for performing high-frequency ablation surgery. Further, the gap between the induction cautery catheter having the groove on the surface and the guide catheter is further increased. Thereby, it is possible to sufficiently satisfy the requirements for contrast, labration, anticoagulation and the like during the high-frequency ablation operation. A radiofrequency ablation catheter having a groove on its surface can be used for cardiac nerve radiofrequency ablation or renal artery radiofrequency ablation.

Example 9
High-frequency ablation surgery directly burns nerves by radiating high-frequency energy at a high-frequency energy radiation point and converting it into thermal energy by a high-frequency electrode in a high-frequency ablation catheter that penetrates the blood vessels of the human body and penetrates the vessel wall. Because of the minimally invasive surgical procedure for the lesion, the diameter of the radiofrequency ablation catheter must be suitable for the diameter of the blood vessel in the human body. The diameter of the human renal artery is in the range of about 2-10 mm. In the prior art, the diameter of the high frequency electrode end of the high frequency ablation catheter is constant and cannot be adapted to the diameter of different blood vessels in different human bodies. Further, in some cases, there is a problem that the high-frequency electrode cannot be applied simultaneously. Therefore, in order to satisfy different patient requirements, high frequency electrodes with different standards must be provided.

  Usually, a radiofrequency ablation catheter for cauterizing the renal arteries includes one or more sets of radiofrequency electrodes. In order to achieve the purpose of electrical resistance measurement and induction cauterization, each set of high frequency electrodes is connected to one or more conductors. The manufacturing method of the prior art induction catheter is as follows. In a normal case, first, a lead wire and an electrode are manufactured. Thereafter, a high-frequency ablation catheter is assembled using the leads, electrodes and catheter. The diameter of the catheter itself is very small, in the range of 1.5 to 2.5 mm, while the lead diameter is in the range of 0.1 to 0.5 mm. There are errors in the dimensions themselves. Moreover, since the conducting wire inside the catheter tube of the high-frequency ablation catheter is quite complicated, the uniformity of the conducting wire cannot be guaranteed. Further, when high frequency energy is radiated, the conductors may interfere with each other. Therefore, the prior art radiofrequency ablation catheter must be improved.

  Hereinafter, the cable type high frequency ablation catheter of the present invention and the manufacturing method thereof will be described with reference to specific examples and drawings.

  The cable type radiofrequency ablation catheter of the present invention includes a control handle, a catheter tube and an electrode part. Among them, one end of the catheter tube is used to connect to the control handle, and the other end of the catheter tube is used to manufacture the electrode part. The central portion of the catheter tube is a through hole. The expansion / contraction control line penetrates the through hole, one end is connected to the control handle, and the other end is fixed to the distal end (that is, the front end) of the electrode part.

In the cable type radiofrequency ablation catheter, the catheter tube includes a plurality of sets of memory alloy wires and metal wires covered with a cable covering layer and insulated from each other. One end of the memory alloy wire is connected to the control handle and the other end is used to manufacture a memory alloy stent. An intermediate portion of the memory alloy stent is exposed to form a conductive portion. Further, the conductive portion is wound with a metal wire, and the electrode material is fixed with the wound conductive wire to form the electrode portion.
Among them, a thermocouple composed of a memory alloy wire and a metal wire is used for measuring the temperature of the high frequency energy radiation point. The memory alloy wire can be manufactured using any one of nickel-titanium alloy, copper-nickel alloy, titanium alloy, and can also be manufactured using other types of materials. . The metal wire can be manufactured using any one of pure copper, copper-zinc alloy, platinum alloy, chromel. The electrode material is platinum and other electrode materials.

  The cable-type high-frequency ablation catheter can be obtained in the catheter tube using the cable manufacturing method. Accordingly, it is possible to realize the distribution of the plurality of conductors in an orderly manner inside the catheter tube body, and it is also possible to prevent the plurality of conductors from interfering with each other. Moreover, in the saddle-shaped high-frequency electrode stent used as the electrode portion, the saddle-shaped high-frequency electrode stent is composed of 4 to 8 cm of high-frequency electrodes. Since the high-frequency electrode is made of a memory alloy, it deforms under the action of an external force. When the external force disappears, the shape of the high-frequency electrode after deformation can be restored to the shape of the high-frequency electrode before deformation. In order to attach the saddle-shaped high-frequency electrode stent tightly to the inner wall of the blood vessel, the shape of the saddle-shaped high-frequency electrode stent must be changed slightly with an appropriate external force. Therefore, clinically, when the shape of the saddle-shaped high-frequency electrode stent inserted into the blood vessel is restored to the shape of rugby football at body temperature, the expansion / contraction control line is pulled by the control handle, thereby expanding the saddle-shaped high-frequency electrode stent. The diameter of the saddle-shaped radio frequency electrode stent (ie, the diameter of the rugby football shape) can be fine-tuned to fully adapt the diameter of the saddle-shaped radio frequency electrode stent to different vessel diameters of different patients.

  A method for manufacturing a cable type radiofrequency ablation catheter will be described using a saddle-shaped radiofrequency electrode stent made of a nickel-titanium alloy wire as an example.

  First, the enameled copper wire 301 and the enamel nickel-titanium alloy wire 302 are previously incorporated in the cable coating layer, and the catheter tube is stretched and formed like a cable by a cable manufacturing method.

  Thereafter, the cable covering layers at both ends of the catheter tube are peeled off, one end of the catheter tube is connected to the control handle, and the other end of the catheter tube is manufactured and molded into an electrode part. Hereinafter, Step 1 to Step 7 for manufacturing the electrode portion using one end of the catheter tube will be described with reference to FIGS. 27a to 27g.

Step 1: As shown in FIG. 27a, after the catheter tube is manufactured, the cable covering layer at the front end (the end close to the high frequency electrode) of the catheter tube is peeled off to form a nickel-titanium wire 302 and an enameled copper wire. Leak 301;
Step 2: As shown in FIG. 27b, the exposed insulating layer of the nickel-titanium wire 302 is peeled off, and the shape of the peeled nickel-titanium wire 302 is shaped into the shape of a saddle-shaped high-frequency electrode stent by holding a mold. Forming a memory alloy stent;
Step 3: As shown in FIG. 27c, the proximal end and the distal end of the nickel-titanium wire 302 are respectively covered and insulated with a heat shrink tube, and the middle portion is leaked to form the conductive portion 303. ;
Step 4: As shown in FIG. 27d, the exposed insulating layer of the enameled copper wire 301 is peeled off, and the peeled enameled copper wire 301 is wound around the exposed portion of the nickel-titanium wire 302 (ie, the conductive portion 303). Turn to form a thermocouple;
Step 5: As shown in FIG. 27e, the enameled copper wire 301 is coated with a platinum ring 304 by covering the wound enameled copper wire 301 and the platinum ring 304 is welded with a solder or bonded with an adhesive. And seal both ends of the platinum ring 304 with a sealing compound;
Step 6: As shown in FIG. 27f, after fixing the platinum ring 304 to the saddle-shaped high-frequency electrode stent made of nickel-titanium wire, the expansion / contraction control line is penetrated into the central hole of the catheter tube body;
Step 7: As shown in FIG. 27g, the distal end of the saddle-shaped high-frequency electrode stent composed of nickel-titanium wire is integrated with the distal end of the expansion / contraction control line 305 by a sealing compound or other method. Fixed.

  In the above, the manufacturing method of the cable type high frequency ablation catheter of the present invention has been described. Among them, the catheter tube is manufactured by a cable manufacturing method. First, the catheter tube is manufactured; then, the electrode part is manufactured. It is a mature manufacturing technology, simple manufacturing process, and easy control. A total of 8 to 18 conductors are distributed in the catheter tube, and each electrode independently performs electrical resistance measurement, temperature measurement and high-frequency energy radiation. Since each set of conductors are insulated from each other, they do not interfere with each other when radiating high frequency energy.

  In the conventional manufacturing method, first, a conducting wire and an electrode are manufactured, and then the conducting wire, the electrode, and the catheter tube are assembled. Compared to the prior art, in the manufacturing method of the present invention, the plurality of conductors inside the catheter tube are distributed in an orderly manner and do not interfere with each other. Thereby, when assembling the high-frequency ablation catheter, the plurality of conductors are prevented from being unevenly distributed, and the plurality of conductors are prevented from interfering with each other.

  The cable type radiofrequency ablation catheter of the present invention further includes a temperature measurement portion. The temperature measurement part is a thermocouple composed of a copper wire and a nickel-titanium wire. Among them, the copper wire is also a high-frequency energy radiation electrode lead and an electrical resistance measurement electrode lead, and temperature measurement, electrical resistance measurement and high-frequency energy radiation are discontinuously performed. According to the verification result of the test, the thermocouple composed of the copper wire and the nickel-titanium wire has a good performance, and the temperature of the human tissue is accurately measured within the working temperature range.

  In the above embodiment, the saddle-shaped high-frequency electrode stent is composed of a nickel-titanium wire. Since the nickel-titanium alloy is a memory alloy, it can be restored to its original shape at a suitable temperature. For example, a high-frequency electrode made of nickel-titanium alloy can be restored to an arcuate shape at body temperature. The high-frequency electrode can also be composed of other memory alloys, such as copper-nickel alloys or titanium alloys. In addition to this, when the nickel-titanium alloy cannot realize a tight sticking wall due to its own deformation, it further controls the deformation of the saddle-shaped high-frequency electrode stent by the expansion / contraction control line, thereby Can be realized by sticking it closely to the blood vessel wall.

(Example 10)
During radiofrequency ablation surgery, especially during renal arterial nerve radiofrequency ablation surgery, during cardiac nerve radiofrequency ablation surgery, and during other neurofrequency ablation surgery, during surgery before surgery, after surgery, cardiac or renal nerve Electrophysiological monitoring measurements must be performed on tissue in the ablation area and on nerve tissue, respectively.

  Since the electrophysiological signal is very weak and the difference between the electrophysiological signals is also minute, these minute fluctuations cannot be monitored and measured by the inspection device. Therefore, the anti-electromagnetic interference function of the monitoring measurement system is an important guarantee for obtaining an accurate monitoring measurement result.

  When performing cardiac nerve radiofrequency ablation surgery and renal artery nerve radiofrequency ablation surgery, the radiofrequency ablation catheter required for the operation is long, and the radiofrequency ablation catheter must be inserted into the heart or renal artery from outside the body during the operation. The path for monitoring is long. Therefore, the degree to which the monitoring and measuring system is subjected to electromagnetic interference is even higher.

  In general, by installing a shielding network on the outer layer wall of a high-frequency ablation catheter, it is possible to reduce interference with electrophysiological signals due to surrounding electromagnetic fields. However, this method increases the overall size of the radiofrequency ablation catheter. As a result, an increase in the outer diameter of the radiofrequency ablation catheter also increases the possibility of damaging the patient's tissue, and radiofrequency ablation surgery cannot be performed on patients with blood vessels having a small diameter.

  A high-frequency ablation catheter must establish a path from the outside of the body to the heart or the renal artery in cooperation with the guide catheter during work, and most of the high-frequency ablation catheter must be retained inside the guide catheter. That is, the outer wall of the high-frequency ablation catheter is covered with the guide catheter during the high-frequency ablation operation. Therefore, the guide catheter having the anti-electromagnetic interference function mentioned in Example 7 and Example 8 will be described with Example 10 as an example. By installing shielding nets on the catheter tube body and rear end interface of the guiding catheter, not only does the electromagnetic interference due to the surrounding electromagnetic field to the internal high-frequency ablation catheter be eliminated or significantly reduced, but also the high-frequency ablation catheter. The outside diameter can be reduced to reduce patient pain. Thereby, it is also possible to provide important guarantees for obtaining accurate monitoring measurement results.

  As shown in FIG. 28, the guiding catheter having the electromagnetic wave interference preventing function of the present invention includes a hollow cylindrical catheter tube body 403, and there is an end port at the front end of the catheter tube body 403. A rear end interface 402 is installed at the rear end. The rear end of the catheter tube 403 means that the catheter tube 403 is the end far from the patient's human body. Among them, the three-way valve 401 is connected to the rear end of the catheter tube 403 by a conduit 407, the hemostasis valve 408 is installed inside the catheter tube 403, and the skin electrode 404 is connected by a lead 407. In addition, a shield net 412 knitted from a conductive material is installed on the catheter tube 403 and the rear end interface 402, and the shield net 412 is pulled out of the rear end interface 402 so as to form a connector 405 on the rear end interface 402. The conductive material is laid across the tube wall of the catheter tube 403 so as to form a shield net 412 having an annular closed shape, and the connector 405 is grounded.

  In order to ensure the safety of the guiding catheter and to prevent damage to the shielding mesh 412 during use, the shielding mesh 412 is installed as an intermediate layer of the catheter tube 403. Thus, the catheter tube 403 is divided into an inner layer 413 of the guiding catheter and an outer layer 414 of the guiding catheter. As is known from FIG. 29c, the screen 412 is knitted from a conductive material. The conductive material is laid across the tube wall of the catheter tube 403 so as to form a shield net 412 having an annular closed shape. It is known from the unfolded shielding net 412 as shown in FIG. 29c, and the shielding net 412 is knitted so that the horizontal and vertical lines exposed when unfolded are at a certain angle. When the shielding net 412 is installed on the catheter tube 403, the horizontal line surrounds the inner layer 413 of the guiding catheter and is wound along the inclined direction, while the vertical line surrounds the inner layer 413 of the guiding catheter. It is wound along an inclination direction opposite to the inclination direction. The horizontal line and the vertical line are wound around the outside of the inner layer 413 of the guiding catheter so as to form a shielding net 412 having an annular closed shape. The shielding net is knitted with a conductive material. The conductive material can be selected from conductive materials such as stainless steel material, nickel-titanium alloy material and carbon fiber. The count of the screen can be changed. For example, the count of the shielding net is selected within a range of 30 pic to 200 pic. Where pic is defined as the number of meshes of the screen per inch.

  Hereinafter, the electromagnetic wave shielding principle of the guide catheter will be described. As shown in FIG. 30, the conductive material is laid across the tube wall of the catheter tube 403 so as to form a shield net 412 having an annular closed shape. When the disturbing electromagnetic wave 414 is radiated to the outer layer 411 of the guiding catheter, the disturbing electromagnetic wave 414 passes through the outer layer 411 of the guiding catheter and reaches the shielding network 412, and only the disturbing electromagnetic wave 415 having a very small amount of radiation is transmitted to the guiding catheter. The interfering electromagnetic wave 416, which is absorbed through the outer layer 411 but has an overwhelming amount of radiation, is totally reflected. Therefore, the electromagnetic interference caused by the surrounding electromagnetic field on the internal high-frequency ablation catheter is remarkably reduced.

  In the above, the installation method of the shielding net | network 412 in a guide catheter and the electromagnetic wave shielding principle of a guide catheter are demonstrated. Hereinafter, the grounding method of the shielding net 412 will be described with reference to FIGS.

  FIG. 31 is a schematic view showing a state in which the shielding net is grounded by the integrated cable. The high-frequency ablation catheter 424 penetrates the inside of the catheter tube body 403 through the rear end interface 402. The high frequency electrode 425 of the high frequency ablation catheter 424 is pulled out from the front end of the catheter tube 403 and acts on the human body. A control handle 422 is connected to the rear end of the radiofrequency ablation catheter 424. A striped connection electrode is mounted inside the high-frequency ablation catheter 424. The front end of the stripe connection electrode extends to the high frequency electrode 425. The rear end of the stripe connection electrode passes through the control handle 422 and is connected to the integrated interface 421.

  In the guiding catheter of the present invention, the shielding net 412 can be grounded by different grounding methods. For example, as shown in FIG. 31, the connector 405 is installed and formed on the pluggable connector 423 and connected to the integrated cable by the pluggable connector 423. The integrated cable passes through the control handle 422 to connect to the integrated interface 421 and is grounded by the integrated interface 421. Alternatively, as shown in FIG. 32, the shielding net 412 is grounded by a skin electrode 404 connected to the rear end interface 402. Among them, the skin electrode 404 is connected to the rear end interface 402, and the skin electrode 404 is grounded. Alternatively, as shown in FIG. 33, the connector 405 of the shielding net 412 is directly grounded by a lead wire.

  In the above embodiment, the hemostasis valve 408 is installed inside the rear end interface 402 of the guide catheter. However, a structure in which the hemostasis valve 408 is not installed inside the rear end interface 402 may be employed. For example, in a guide catheter that does not include a hemostasis valve and has a hemostasis valve, as shown in FIG. 34, a shield net 412 knitted with a conductive material is connected to a catheter tube 403 and a rear end as in the guide catheter provided with a hemostasis valve. Can be installed on the interface 402. In addition, the shielding net 412 forms a connector 405 at the rear end interface 402. The connector 405 can be directly grounded as shown in FIG. 34, and can be grounded by a skin electrode 404 or an integrated cable connected to the connector 405.

  In the embodiment as shown in FIGS. 31 to 33, a hemostasis valve 408 is installed inside the rear end interface 402. The three-way valve 401 is connected to the rear end interface 402 via a conduit 407. In order to satisfy the requirements for contrast, labration, anticoagulation, etc. in radiofrequency ablation surgery, a contrast medium for contrast, physiological saline for labration, and heparin for anticoagulation are catheterized by a three-way valve 401. The tube body 403 can be injected.

  In Example 10 as shown in FIG. 34, the hemostasis valve 408 is not installed in the rear end interface 402. Further, the three-way valve 401 is not connected to the rear end interface 402. A three-way valve 409 may be connected to the back end interface 402 to facilitate infusion of contrast media for contrast, saline for labration, and heparin for anticoagulation into the catheter tube 403. it can. To obtain a sealing effect, the three-way valve 409 can be connected to the rear end interface 402 in a screwed manner. At the same time, a shielding net 430 knitted with a conductive material is also installed inside the three-way valve 409 in order to secure the electromagnetic wave interference preventing function of the guide catheter. The shielding net 430 is grounded by the drawn connector.

  In the guide catheter known in the above and having an anti-electromagnetic interference function in Example 10, the internal high-frequency ablation catheter is electromagnetically shielded by installing a shielding network on the catheter tube, and the surrounding electromagnetic field with respect to the high-frequency ablation catheter Electromagnetic interference due to can be eliminated or significantly reduced. Furthermore, by using a guiding catheter equipped with a shielding network for cardiac nerve radiofrequency ablation surgery or renal artery radiofrequency ablation surgery, the influence of the surrounding electromagnetic field on physiological signals can be removed, and accurate monitoring measurement results can be obtained. Can do. In addition, by using the catheter tube provided with the shielding net, the outer space of the high-frequency ablation catheter can be reduced while the internal space of the guiding catheter is effectively used. In addition, the strength of the catheter tube of the guide catheter can be improved by using a net-shaped shielding net structure.

  In summary, in the high-frequency ablation method of the present invention, by using the guidance parameters and monitoring and measuring the process of the high-frequency ablation operation using the temperature monitoring measurement module and the volume impedance measurement module, Safe and controllable implementation can be guaranteed. At the same time, the high-frequency electrode, high-frequency ablation catheter, and guiding catheter in the high-frequency ablation apparatus of the present invention have various features, thereby further improving the accuracy of the high-frequency ablation surgery and further reducing damage to the patient's blood vessels. Can prevent the occurrence of complications.

  The induction cautery method, system, and induction cautery apparatus of the present invention have been described in detail above. The present invention is not limited to what is shown in the drawings; and what is described herein. In other words, all changes and modifications made by the appended claims and their equivalents should belong to the technical scope of the present invention.

1 central processing unit and control module 2 high frequency energy radiation module,
DESCRIPTION OF SYMBOLS 3 Volume impedance measurement module 4 Temperature monitoring measurement module 5 Alarm and automatic memory module 6 Intracavity optical tomography processing module 7 Intracavity ultrasonic image processing module 10 High frequency ablation catheter 11 Mark part 12 which has radiopaque property High frequency electrode 13 Perforated wall portion 14 Opening portion 15 Mark portion having radiopacity 16 Guide catheter 17 Catheter branch 20 Control handle 21 Catheter guide control handle 22A Stretched position 22B Curved position 23 Catheter electrode control handle 24 Catheter electrode control assist Handle 25 Opening position 26 Closing position 27-29 Arrow 31 End side 32 of catheter in integrated cable Plug flange 33 Integrated cable connecting part 34 Integrated cable 35 Temperature control type high-frequency heat condensing device 36 Display device (ie, monitoring device)
37 Temperature control type high frequency heat condensation apparatus side end portion 38 in the integrated cable Temperature control type high frequency heat condensation apparatus side end connection socket 50 in the integrated cable The catheter side end connection socket or integrated interface 60 in the integrated cable Provided high-frequency electrode 61 High-frequency electrode 62 Pointed protrusion-type perforated wall 63 Support guide metal stripe 64 Striped puncture high-frequency electrode 65 Perforated electrode 66 Electrode sac 67 Electrode protective shell 81 Endovascular membrane 82 Vascular smooth muscle layer 83 Perivascular plant Nervous plexus 84 Perivascular tissue 91 Area of thermal energy distribution in single-point high-frequency electrode 92 Direction of thermal energy transmission in blood flow 95 Area of thermal energy distribution in high-frequency electrode with perforated wall 101 101a Base material 102 Second material 103 Common ground wire 1 04 Effect line 110 Support guide metal stripe 111 A Electrode tip part 111 B Electrode support part 111 Puncture high frequency electrode 112 Second material 113 Common ground line 114 Effect line 115 Stretching control line 120 Joiner 120 'Metal ring 121 Sine wave generation module 122 Signal multiplication module 123 Power amplification module 124 Switch module 125 High frequency electrode conductor 126 High frequency electrode 127 Thermocouple conductor 128 Body surface electrode, body surface electrode conductor 129 Central processing unit 130 Output voltage / current monitoring measurement module 131 Temperature data collection module 132 Data Display module 133 Control module 134 Electric resistance 201 of human body Support catheter 202 Conductor 203 Sealing layer 210 High-frequency ablation catheter 210 'provided with grooves on the surface Conventional cylindrical high-frequency ablation catheter 220 Guide catheter 301 Enamelled copper wire 302 Nickel-titanium alloy wire 303 Conductive portion 304 Platinum ring 401 Three-way valve 402 Rear end interface 403 Catheter tube 404 Skin electrode 405 Connector 406 Lead wire 407 Conduit 408 Hemostatic valve 409 Three-way valve 411 Guide catheter Outer layer 412 Shielding net 413 Guide catheter inner layer 414 Interference electromagnetic wave 414
415 Interfering electromagnetic wave 416 with extremely small radiation amount 416 Interfering electromagnetic wave 421 with overwhelmingly large radiation amount Integrated interface 422 Control handle 423 Pluggable connector 424 High-frequency cautery catheter 425 High-frequency electrode 430 Shielding network A Joint welding point A
B Junction interfaces S1-S3 switch between nickel-titanium alloy and copper-zinc alloy

Claims (10)

Includes an induction cautery catheter, a control handle and a temperature controlled induction heat condensing device
A stripe-shaped connection electrode is mounted on the intermediate portion of the high-frequency ablation catheter, a high-frequency electrode is formed at the distal end of the high-frequency ablation catheter, and the high-frequency electrode is connected to the control handle by the stripe-shaped connection electrode,
The control handle includes a catheter guide control handle for controlling the degree of bending of the distal end of the radiofrequency ablation catheter, and a catheter electrode control handle and a catheter electrode control auxiliary unit for controlling the degree of spreading of the radiofrequency electrode. Including the handle,
An integrated interface is installed at the rear end of the control handle, and the temperature-controlled high-frequency heat condensation apparatus is connected to the integrated interface installed in the control handle by an integrated cable,
The catheter tube of the high-frequency ablation catheter is a cable-integrated catheter tube manufactured by a cable manufacturing method, and the catheter tube is coated with a cable coating layer and insulated from each other with a plurality of memory alloy wires. Including a metal wire, wherein the memory alloy wire has one end connected to a control handle and the other end used to manufacture a memory alloy stent, an intermediate portion of the memory alloy stent is exposed to form a conductive portion; further, the conductive portion wound with the metal wire, and electrode material, forms an electrode portion covers the wound wires, radio frequency ablation equipment, characterized in that. Including a guide catheter installed outside the high-frequency ablation catheter, the guide catheter having an anti-electromagnetic interference function,
The guide catheter includes a hollow cylindrical tube body, the tube body has an end at the front end, a rear end interface is installed at the rear end of the tube body, and the tube body and the rear end interface are A shield net knitted from a conductive material, the conductive material laid across the tube wall of the tube so as to form a shield net having an annular closed shape, and the shield net is 2. The induction cautery equipment according to claim 1, wherein the rear end interface is pulled out from the rear end interface so as to form a connector, and the connector is grounded. The high-frequency electrode has both a temperature measurement function and a volume impedance measurement function,
The high-frequency electrode includes a high-frequency energy radiation point, and the high-frequency energy radiation point is simultaneously a volume impedance measurement point,
A thermocouple for measuring temperature is formed by bonding a second material to the high-frequency electrode, the second material is a material different from a material for forming the high-frequency electrode, and the second material is: 2. The high frequency cautery equipment according to claim 1, wherein the high frequency electrode is connected to the high frequency electrode by any method of welding, electroplating, sleeve joint, and pressure bonding. A groove is formed on the surface of the induction cautery catheter,
The high-frequency ablation catheter includes a support catheter disposed at a central portion of the high-frequency ablation catheter, and a plurality of conductors disposed on an outer surface of the support catheter, and the plurality of conductors is a circumference of the support catheter. Each of the conductive wires is extended along the length direction of the support catheter, and a sealing layer for covering the conductive wires is disposed outside each of the conductive wires, The induction ablation equipment according to claim 1, wherein the adjacent sealing layer forms a groove on the outer surface of the support catheter.   The high-frequency ablation equipment according to claim 1, wherein one end of the catheter tube is used for connecting a control handle, and the other end of the catheter tube is used for manufacturing an electrode part. . Including a central processing unit, a sine wave generation module, a signal amplification module, a power amplification module, a switch module, a high frequency electrode module, an output voltage / current monitoring measurement module, and a temperature data collection module,
The sine wave generation module is connected to the central processing unit, and the high-frequency electrode module is connected to the central processing unit through the switch module, and the sine wave generation module, the signal amplification module, and the power amplification module The switch modules are sequentially connected to the high frequency electrode module, the output voltage / current monitoring and measuring modules are connected to the central processing unit and the power amplification module, respectively, and the temperature data collection modules are respectively connected to the central processing unit. Connected to the switch module,
The central processing unit controls the switching module to switch the operation mode, and the central processing unit generates the sine wave having a frequency corresponding to the operation mode. The sine wave is signal amplified by the signal amplifying module, further power amplified by the power amplifying module, and finally transmitted to the high frequency electrode through the switch module. When switching to the resistance measurement operation mode, the output voltage / current monitoring measurement module measures the current and voltage output by the power amplification module and feeds back the current and voltage to the central processing unit. However, the switch module switches the operation mode to the temperature measurement operation mode. The temperature data collection module measures current flowing through the high-frequency circuit and feeds back the temperature data calculated through calculation to the central processing unit. Temperature-controlled high-frequency heat condensing equipment used in high-frequency cautery equipment. The switch module includes switches (S1, S2, S3) installed in parallel; the high-frequency electrode module includes a high-frequency electrode, a thermocouple made of a high-frequency electrode and a second material, and a body surface electrode; 3 Each of the switches (S1, S2, S3) is used by being connected to a high-frequency electrode conductor, a thermocouple conductor, and a conductor connected to the body surface electrode; the high-frequency electrode conductor is simultaneously used as the thermocouple conductor, and The high-frequency electrode conductor and the thermocouple conductor are connected to the high-frequency electrode and the second material joined to the high-frequency electrode, respectively; the first switch (S1) and the second switch (S2) of the switch module are switched on The high-frequency electrode and the second material joined to the high-frequency electrode form a thermocouple measurement circuit; the first switch (S1) of the switch module; And the third switch (S3) are switched on, the high-frequency electrode and the body surface electrode form a high-frequency energy radiation circuit, or the switch module is a switch (S1, The high-frequency electrode module includes a high-frequency electrode, a thermocouple composed of the high-frequency electrode and a second material, and a second high-frequency electrode; each of the three switches (S1, S2, S3) includes Used as a high-frequency electrode lead, a thermocouple lead, and a lead connected to the second high-frequency electrode; the high-frequency electrode lead is another thermocouple lead, and the high-frequency electrode lead and the thermocouple lead are respectively The high-frequency electrode is connected to a second material bonded to the high-frequency electrode; a first switch (S1) and a second switch (S2) of the switch module When switched on, the high frequency electrode and the second material joined to the high frequency electrode form a thermocouple measurement circuit; the first switch (S1) and the third switch (S3) of the switch module The temperature-controlled high-frequency heat condensing device according to claim 6, wherein the high-frequency electrode and the second high-frequency electrode form a high-frequency energy radiation circuit when switched on. The center of the integrated interface includes multiple channels,
The high-frequency ablation equipment according to claim 1, wherein a volume impedance interface, a temperature control interface, and a high-frequency electrode interface are installed outside the multi-channel. The shape of the electrode material is a ring shape, wherein the electrode material covers the wound wires, radio frequency ablation equipment according to claim 5, characterized in that.   The temperature-controlled high-frequency heat condensation apparatus includes a central processing unit and a control module, a high-frequency energy radiation module, a volume impedance measuring module, a temperature monitoring and measuring module, and the central processing unit connected to the central processing unit and the control module, respectively. The induction cautery facility of claim 1 including an alarm and automatic storage module connected to the apparatus and control module.

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